Associate Director, Global Submission Management
$163.2k - $244.8kVertex Pharmaceuticals
- # Associate Director, Global Submission ManagementApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29521**Job Description****General Summary:**The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This role will manage submissions for development‐stage, lifecycle, regional, and post‐approval, as well as supporting activities required to enable, maintain, and advance global product registrations. The disease area focus of this role will be Pulmonary or Cell & Gene Therapy.This role ensures routine, regional, and lifecycle submissions are delivered efficiently, compliantly, and predictably in alignment with global regulatory strategies and operational objectives. This role partners closely with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions to support coordinated submission planning, execution consistency, and steady‐state portfolio throughput.**Key Duties and Responsibilities:*** Provides oversight for a defined portfolio of regulatory submissions, from planning through submission and closeout* Develops and maintains submission plans, timelines, and tracking across multiple programs* Ensures consistent application of submission management standards, tools, and processes* Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables* Coordinates cross‐functional activities to ensure submission completeness, quality, and compliance* Identifies, manages, and resolves operational risks affecting submission timelines or quality* Oversees preparation of submission status updates, issue logs, and portfolio‐level reporting* Supports workload planning and capacity management across the submission portfolio* Escalates risks appropriately when submissions approach higher‐impact or higher‐complexity thresholds* Leads, coaches, and supports submission management staff including vendor functional service providers (FSPs)* Contributes to continuous improvement, knowledge sharing, and talent development within submission management* Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI driven tools, and maintains a continuous learning mindset to strengthen GSM decision-making and operational efficiency* Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.**Knowledge and Skills:*** Strong knowledge of global regulatory submission requirements, processes, and timelines* Experience with submission and project management tools and systems* Ability to manage multiple concurrent submissions and competing priorities* Strong organizational, planning, and problem‐solving skills* Effective stakeholder management and cross‐functional communication skills* Ability to drive execution consistency, compliance, and operational efficiency**Education and Experience:*** Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline* 7+ years of experience in regulatory submission management, regulatory operations, or regulatory/clinical project management* Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions* Experience working effectively in matrixed, cross‐functional environments* People‐management experience preferred* Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM* Experience managing submissions in Pulmonary or Cell & Gene Therapy is preferred#LI-Hybid**Pay Range:**$163,200 - $244,800**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io### About Vertex## **Help Us Achieve Our Mission**## *Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency* *.**Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit ** or follow us on Facebook,* *Twitter/X* *, LinkedIn, YouTube and Instagram.**The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.**Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.*
- J-18808-Ljbffr Vertex Pharmaceuticals
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Associate Director, Global Submission Management in Boston, MA vacancy
$185.37k - $308.95k
...Associate Director, Global Safety Lead Who we are: At Agios, we are fueled by connections to transform... ...our growing Medical Safety and Risk Management team. We want someone who cares... ...informed consent forms, and regulatory submissions including IND, NDA and PIP/PSP...SuggestedTemporary workRemote workWork from homeFlexible hours3 days per weekKinsley Power Systems
Cambridge, MA2 days ago$154.4k - $242.55k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry... ...the development of robust and accurate submissions. Develops constructive relationships... ..., develops, plans, executes and manages regulatory submissions per the GRA CMC Product...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwideTakeda Pharmaceutical Company Ltd
Boston, MA5 days ago$154.4k - $242.55k
...patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will... ...for oncology programs, oversee major submissions, and guide cross-functional teams to... ...with health authorities and lead and manage FDA meetings. Define strategies, provide...SuggestedMinimum wageTemporary workLocal areaWorldwide$169.4k - $266.2k
...your best. As part of the Global Medical Affairs Oncology team... ...and deliverables, the Associate Director, Scientific Communications... ...sciences, and excellent project management skills. The Associate Director... ...decks, NCCN or pathway submissions, animations, and digital amplification...SuggestedMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work$273.21k - $331.06k
Functional Area Description The Associate Director, Global Clinical Physician sits within Clinical... ...oversight for clinical trials Matrix management responsibilities across the internal... ...reports, briefingbooksand submission documents to support closure, clinical...SuggestedHourly payFull timeTemporary workPart timeSummer workFlexible hours$126k - $190k
...leading pharmaceutical company is seeking an Associate Director, Safety Scientist to lead risk management in Global Patient Safety. This role involves managing safety... ...for junior staff, and supporting regulatory submissions. Candidates should have a bachelor's degree in...$112.18k - $168.26k
...The Associate Director, Global Sourcing will develop strong partnerships with functional leaders in the management of external spending supporting Medical Affairs and Marketing. Collaborating with functional leadership, develop and implement global sourcing category strategies...Hourly payContract workTemporary workLocal areaDormont Manufacturing Company
Boston, MA2 days ago- Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston, MA. This role involves leading global regulatory strategies for oncology programs, overseeing major submissions, and guiding cross-functional teams to deliver breakthrough treatments. The...Worldwide
- Takeda in Boston, MA seeks an Associate Director, Global Regulatory Lead Oncology to define and lead... ...for oncology programs, oversee major submissions, and guide cross-functional teams to... ...the primary FDA contact for projects, managing US FDA submissions, and coordinating...
- ...Pharmaceuticals Inc (US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their portfolio. The role involves leading regulatory submissions and mentoring team members on regulatory frameworks and...
$153.6k - $241.34k
...application is true to the best of my knowledge. Job Title: Associate Director, Scientific & Competitive Analysis, Global Oncology Location: Cambridge, MA Responsibilities... .../external partnership opportunities. Project manage and provide operational excellence; engage in data...Full timeTemporary workRemote work$154.4k - $242.55k
Job Title Associate Director, Scientific & Competitive Analysis, Global Oncology Company Takeda Pharmaceutical Location Cambridge, MA Job Overview This position... ..., brand planning, situation analysis, project management and cross‑functional alignment. The role also serves...Full timeTemporary workLocal areaRemote work- ...Pharmaceuticals Inc in Boston, MA, is seeking an Associate Director for Heme CGT Business Systems to lead global system strategy for CASGEVY. You will own the product... ..., and prioritize commercial capabilities while managing cross-functional teams and driving continuous...
$211.91k - $256.79k
Associate Director, Global Clinical Science Reports through the Clinical Development function which provides scientific expertise necessary to... ...leads study team meetings in partnership with GDO protocol manager and collaborates with cross‑functional study team members....Hourly payFull timeTemporary workSummer workFlexible hoursShift work$211.91k - $256.79k
Myana is seeking an Associate Director for Global Clinical Science to lead implementation and execution of clinical trials. This role demands thorough protocol understanding, skilled collaboration with cross-functional teams, and scientific leadership in delivering high...$199k - $236k
Position Overview Bicara Therapeutics is seeking an Associate Director, Global Scientific Communications, who will lead the development and execution... ...guidelines. Vendor & Budget Oversight: Partner with and manage external scientific communication and medical writing...Work at officeLocal area3 days per week$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...candidate will need to successfully manage multiple projects in a fast and... ...CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory...Permanent employmentWork at officeWork from home$162.8k - $244.2k
Position Summary We are seeking an Associate Director, Heme CGT Business Systems to lead global system strategy for CASGEVY. Key Responsibilities Own the product... ...systems, tools, and processes. Lead change management efforts to support successful implementation, stakeholder...Work experience placementSummer workRemote workFlexible hours2 days per week$131.04k - $196.55k
Senior Manager/Associate Director, Global Safety Scientist, MSRM Agios Pharmaceuticals is searching for a dynamic Global Safety Scientist to join our growing Medical Safety & Risk Management team. We want someone who cares about this important work, and who’s driven to...Temporary workRemote workWork from homeWorldwideFlexible hours3 days per week$154.4k - $242.55k
Job Title Lead, Global Pricing, Oncology (Associate Director) Location Cambridge, MA About the role Will lead the development of global pricing strategies... ...Finance leads to ensure data sharing and efficient management of price decisions and KPIs. Own key relationships...Temporary workLocal area$154.4k - $242.55k
Initial Therapeutics, Inc. is seeking an Associate Director, Global and US Pipeline Forecasting Lead in Boston, MA. This role will drive the forecast... ...a focus on oncology. The position requires strong project management skills and the ability to explain complex concepts clearly...$83k - $95k
Responsibilities Lead operational planning and implementation for global programs and partnerships, including international travel, events, and performances. Manage academic directors, faculty, staff, alumni artists, consultants, temporary employees, and student travelers...Temporary workLocal areaWeekend workAfternoon shift$112.18k - $168.26k
AstraZeneca GmbH is seeking an Associate Director, Global Sourcing based in Boston, MA. This role will involve developing partnerships and sourcing... ...pharmaceutical industry, demonstrating a strong ability to manage cross-functional relationships and strategic sourcing. The...$185.37k - $308.95k
Agios Pharmaceuticals is seeking an Associate Director, Global Safety Lead to join their Medical Safety and Risk Management team in Cambridge, MA. The role involves developing safety strategies for clinical protocols while ensuring timely address of safety issues. Ideal...Remote job$162k - $223k
## Associate Director, Global Medical Strategy & Execution - Alzheimer's DiseaseApplyremote type: Hybridlocations: Cambridge, MAtime type: Full timeposted... ...execution, including ongoing monitoring,* Develop and manage strategic content, leadership updates, and materials for...Temporary workFor contractorsLocal area- ...serious diseases. We are seeking an Associate Director, PV Case Operations to join our Global Patient Safety team, supporting... ...processing, distribution, and submission. Own ICSR quality standards... ...clearly with senior management and partners. This role requires...Worldwide
$154.4k - $242.55k
Job Description The Associate Director Launch/Pre Launch Forecasting Lead is responsible for driving... .... This role sits within the larger Global Insights and Analytics organization in... ...‑matrixed environment Strong project management skills—ability to plan, prioritize and...Minimum wageFull timeTemporary workLocal areaRemote work- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization... ...and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert...Full timeRemote workWorldwide
$161.5k - $218.5k
Alnylam Switzerland GmbH is seeking an Associate Director of Procurement Operations in Cambridge, MA to oversee global procurement activities. The role involves leading a team and working closely with finance, legal, and sourcing to enhance buying experiences and ensure...$154.4k - $242.55k
Job Description About the role: The Associate Director, Global and US Pipeline Forecasting Lead is responsible for driving the forecast strategy... ...working in a highly matrixed environment Strong project management skills—ability to plan, prioritize and execute multiple...Full timeTemporary workLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Global Submission Management. Be the first to apply!
Related searches
- associate business manager Boston, MA
- associate director operations Boston, MA
- associate director clinical data management Boston, MA
- associate director clinical research Boston, MA
- associate media manager Boston, MA
- associate product manager web Boston, MA
- associate manager Boston, MA
- associate medical director Boston, MA
- associate clinical manager Boston, MA
- associate director communications Boston, MA