Senior Regulatory Affairs Manager
Katalyst Healthcares and Life Sciences
- The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle.
- GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
- It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence.
- The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
- The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
- This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals.
- In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.
- The Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and execute upon the global clinical and nonclinical regulatory strategies throughout a program's lifecycle that are in alignment with corporate goals and timelines.
- This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
- The Company's Associate Director is viewed as a subject matter expert in the functional area involved in developing, modifying and executing on product strategies and have a function and may have a companywide impact.
- The AD will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and actions leveraging their advanced Nonclinical / Clinical knowledge.
- Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle.
- Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
- Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate
- In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
- Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
- Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
- Lead/support strategy for life-cycle expansion opportunities
- Clinical and Nonclinical Development Plan Advancement
- ct as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
- Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
- Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 6 + year experience with PhD; 8+ years with Masters or bachelor's degrees
- Nonclinical / Clinical Regulatory Affairs experience preferred
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Manager in Boston, MA vacancy
- A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Senior
- ...Senior Vice President, Head of Compliance About the Company Accomplished provider of personal loans & related services... ...Risk Officer, and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves collaborating...Senior
- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...SeniorFull timeRemote work
Barrington James
Boston, MA4 days ago $272.57k - $327.09k
...your development at every step. The Senior Director, Global Regulatory Strategy will be responsible for providing... ...registration and lifecycle management of unique and technologically complex... ...(e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional...SeniorTemporary workWork at office3 days per weekAstraZeneca
Boston, MA3 days ago$212k - $333.19k
...changing therapies to patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...development, registration, commercialization and life‑cycle management with a focus on Human Factors, ensuring that regulatory filings...SeniorFull timeTemporary workLocal areaWorldwideNight shift$245k - $300k
...Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory strategies across... ...expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical...SeniorLocal areaMeridabio
Cambridge, MA2 days ago$270k - $350k
The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities... ...manner across global markets. Independently manage the development of high-quality regulatory documents, including...SeniorShift work$130k - $170k
...trends. Contribute to the continued development of cyber risk management processes. Qualifications 6+ years of experience in cybersecurity... ...such as NIST CSF, ISO 27001, or PCI DSS, and familiarity with regulatory environments such as GDPR, HIPAA, or other privacy and data...SeniorFull timeWork at officeRelocationWHOOP
Boston, MA1 day ago$250k - $280k
...growth, product lifecycle, and market expansion. Serve as the accountable Compliance & Ethics business partner for Commercial, Medical Affairs, Patient Services, and Patient Advocacy. Represent Compliance in cross-functional leadership discussions and embed compliance into...Senior$137k - $165k
...Overview The Senior Manager, Global Trade Compliance – Export Compliance is a strategic leadership... ...programs, and ensure adherence to regulatory requirements across all jurisdictions in... ..., Legal, Treasury, Government Affairs to interpret and operationalize trade regulations...SeniorFull timeTemporary workPart timeWork at officeLocal areaSocket
Boston, MA3 days ago- ...employees to be onsite five days per week. Role Senior Director, Healthcare Compliance,... ...key external‑facing functions (Medical Affairs, Patient Services, and Patient Advocacy)... ...leader, fostering a “speak‑up” culture. Regulatory Intelligence & Governance Maintain deep...SeniorWork at office
- ...Senior Director, Principal Gifts About the Company Philanthropic organization supporting Indigenous culture & individuals Industry Non-Profit Organization Management Type Non Profit Founded 2017 Employees 11-50 Categories ~ Non-Profit & Philanthropy...Senior
- Job Title: Senior Director, Access Strategy, Rheumatology Location... ...Reports To: General Manager, Rheumatology About The... ...and adapt to changes in the regulatory and reimbursement landscape,... ...Services, Brand Strategy, Medical Affairs, Regulatory, Patient Support...SeniorFull time
BioSpace
Cambridge, MA10 days ago - ...Commercial Officer (CCO) will serve as the senior executive commercial leader at TriNetX,... ...)network opertaions, sales, and account management to deliver cohesive growth across all... ...Positioning : Monitor industry trends, regulatory developments, and competitive dynamics across...Local area
TriNetX, LLC
Cambridge, MA2 days ago - ...The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Travel business. In this high-visibility role, you will support strategic planning,...Senior
Doist
Boston, MA1 day ago - ...We are proud to partner with an innovative biotechnology company in the search for a Senior Director, Regulatory Affairs . This fully remote role (US or Canada) will lead regulatory strategy, execution, and compliance across discovery, development, and manufacturing, with...Remote work
RPM ReSearch
Boston, MA3 days ago - ...created by a consortium of leading investment management firms that seeks to lower trading costs,... ...firm, to play a leadership role as a senior team member supporting the growth of the... ...to ensure that Luminex adheres to regulatory requirements, as well as policies and standards...
CERES Group
Boston, MA5 days ago - ...diligence on all third party service providers. Develop and perform training and continuing education for all employees. Perform management training and continuing education for Compliance Team. Approve and monitor all employee personal trading activities as...
Back Bay Staffing Group
Boston, MA1 day ago - ...dealer policies and procedures design to ensure compliance with the regulatory framework imposed by the SEC, the Financial Industry Regulatory... ...other federal and state securities laws and regulations. Manage broker-dealer regulatory examinations, as applicable, and draft...Immediate start
Back Bay Staffing Group
Boston, MA1 day ago - ...System - Compliance & Privacy Program Sr. Manager - Full Time Position Summary - 40 hr/wk.... ...as assigned in collaboration with the Senior Compliance Auditor and under the direction... ...experience in health care law and regulatory matters. Certification/Licensure: Healthcare...SeniorFull timeTemporary workPart timeWork at officeLocal areaFlexible hours
$150k - $250k
...Senior / Principal Neuromorphic Systems Architect Cambridge, MA USA The Company Flagship Labs 119 Inc. (FL119) is an early-stage technology company pioneering a new frontier at the intersection of neuroscience and computation. We are developing next-generation...SeniorFlexible hoursFlagship Pioneering
Cambridge, MA1 day ago- ...candidate will be responsible for leading and maintaining the firm's regulatory compliance program, serving as the primary liaison for... ...with federal and state regulatory requirements, as well as the management of tax reporting and withholding compliance. The Head of Compliance...
Confidential
Boston, MA2 days ago $143k - $191.65k
...supports the innovation of advanced materials, such as next-gen batteries and semiconductors. How will you make an impact? The Senior Manager in Corporate Strategy will play a crucial role in developing the company's long-term strategy. This includes identifying growth...SeniorTemporary workWork at officeThermo Fisher Scientific
Watertown, MA1 day ago- ...overseeing the implementation of the U.S. compliance regime, managing the compliance technology suite, maintaining annual corporate... ..., and ensuring that all products and services comply with the regulatory landscape. Applicants for the Chief Compliance Officer position...
Confidential
Boston, MA3 days ago - Regulatory Affairs Manager - Katalyst CRO Join to apply for the Regulatory Affairs Manager role at Katalyst CRO. Responsibilities Overseeing the... ...relationships. Managing day‑to‑day activities for less senior Regulatory Affairs professionals, including mentoring, coaching...Contract workWork at officeWorldwide
$136k - $170k
...Senior Manager, Forecasting and Analytics The Senior Manager, Forecasting and Analytics reports to the Director, Forecasting and Launch Readiness and is responsible for building robust commercial forecasts, generating decision‑ready analyses, and developing perspectives...SeniorSarepta Therapeutics
Cambridge, MA2 days ago$110k - $125k
...Strategic Communications Manager Aptima is a technological leader in the national security industry. Our mission is to drive the future... ...partners across the entire organization including executives, senior managers, technical teams, and business development managers....SeniorWork experience placementAptima
Boston, MA1 day ago- ...Head of Compliance About the Company One of the world’s largest asset managers with consistent growth and stability. Industry Investment Management Type Privately Held About the Role The Company is seeking a Head of Compliance – US to join their...
$130.8k - $209.4k
...planning and closing. Here’s What You’ll Do FP&A Planning & Reporting Manage the CMC FP&A planning cycles and variance analysis. Serve as the... ...deliver succinctly and effectively deliver recommendations to senior leaders, frames complex concepts. Prior experience working in a...SeniorWork from homeWorldwideInitial Therapeutics, Inc.
Cambridge, MA2 days ago- ...The Position Senior Principal Statistician A healthier future. It's what drives us to innovate. To continuously advance science... ...accelerating timelines to advance Roche's clinical pipeline and promote regulatory success - ultimately bringing medicines to our patients faster....SeniorLocal area
Genentech
Boston, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Manager. Be the first to apply!
Related searches
- regulatory affairs manager pharmaceutical Boston, MA
- manager regulatory affairs Boston, MA
- regulatory cmc manager Boston, MA
- corporate compliance manager Boston, MA
- training and compliance manager Boston, MA
- regulatory manager Boston, MA
- compliance manager Boston, MA
- compliance director Boston, MA
- director global regulatory affairs Boston, MA
- regulatory & compliance manager Boston, MA