Senior Director, Regulatory Affairs
Scorpion Therapeutics
Senior Director of Regulatory Affairs responsible for developing and executing global regulatory strategies across Ardelyx's product portfolio, supporting pipeline and marketed therapeutics.
Responsibilities
- lead regulatory planning for early development through post-approval
- manage interactions with FDA, EMA, and other authorities
- oversee IND/CTA, BLA/NDA, and MAA submissions
- and ensure regulatory compliance and readiness.
- Collaborate with Clinical Development, Medical Affairs, and leadership, providing strategic guidance on trial design, regulatory pathways, and risk management.
- Lead and mentor the regulatory team, monitor evolving regulatory landscapes, and communicate impact to stakeholders.
Requirements
- bachelor's degree in life sciences or related field
- 12+ years of regulatory experience in pharma/biotech, with a proven track record in BLA/NDA/MAA submissions.
- Deep expertise in FDA regulations (21 CFR, ICH), with knowledge of EMA and global frameworks.
- Strong leadership, strategic thinking, and stakeholder management skills
- RAC certification (preferred).
- High-Value: experience with biologics, small molecules, gene therapy, or combination products
- global regulatory experience
- familiarity with expedited pathways like Breakthrough Therapy or Fast Track
- working knowledge of international regulations.
Work setup: not specified.
#J-18808-LjbffrVacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Director, Regulatory Affairs in Waltham, MA vacancy
$195k - $330k
...make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader... ...to program teams and senior leadership.Manage and support junior... ...degree preferred but not required.Director: 8-10 years of Regulatory Affairs experience. Senior Director: 10-12...SeniorFlexible hours$220k - $370k
...Job Description Job Description Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part...SeniorSummer workWork at officeFlexible hoursCompass Therapeutics
Brighton, MA23 days ago- ...clients seeking world-class professional resources.Job DescriptionUS Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for... ...according to EEO guidelines.SummaryType: ContractFunction: ManagementExperience level: Mid-Senior LevelIndustry: PharmaceuticalsSeniorFor contractors
$210k - $320k
...cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence...SeniorFull timeShift work3 days per week1 day per week$275k - $315k
...Position OverviewBicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory...SeniorFull timeTemporary workWork at officeLocal area3 days per weekBicara Therapeutics
Boston, MA2 days ago$195k - $330k
...the development and execution of global regulatory CMC strategies for degrader programs across... ...strategic regulatory CMC guidance to senior leadership regarding health authority interactions... ...readiness.Scale and lead the Regulatory Affairs CMC function as the pipeline and...Senior$250k - $280k
...who need it most.We are seeking a strategic, enterprise-minded Senior Director, Healthcare Compliance reporting to VP, Head of Compliance to... ...organization and key external-facing functions (Medical Affairs, Patient Services, and Patient Advocacy).This leader will shape...SeniorWork at office$218.06k - $327.09k
...role: Are you ready to set the global regulatory vision for pioneering cell... ...patients.You will report to the Executive Director, Cell Therapy Regulatory Affairs and act as a franchise global... ...risks, trade-offs and mitigations to senior leadership to enable decisive, data...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$250k - $273k
...patients who need it most.We're seeking a Senior Director, Quality Compliance reporting to the VP... ...programs, ensuring alignment with regulatory requirements and industry best practices... ...regions.Collaborate with CMC, Regulatory Affairs, Clinical, Pharmacovigilance, and...SeniorWork at office$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- ...ID31521196Reference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining approval... ...Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and... ...collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on...Senior
- Job-ID32387836Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within...Senior
$233k - $280k
...fully integrated commercial company. The Director, Business Strategy & Operations – Commercialization... ...Dyne advances toward launch. Acting as a senior strategic and operational partner to the... ...in partnership with Corporate Affairs.Help strengthen Commercial team culture by...SeniorFull timeWork at officeLocal area$134k - $149k
...motivated, and passionate about science to join our Regulatory Strategy team. As Senior Manager of Regulatory Affairs, the successful candidate will play an important... ...across R&D. This role reports to the Executive Director, Head of Orexin Regulatory Strategy.Why join...SeniorWork at officeLocal areaFlexible hours3 days per week- ...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, MA12 hours ago $84 - $89 per hour
...Description Job Description Job Title: Senior Manager Clinical Compliance Job... ...remain in a constant state of readiness for regulatory inspections. Develop, implement, and... ...Operations, Clinical Development, Medical Affairs, Medical Monitoring, Pharmacovigilance,...SeniorContract workTemporary workRemote workActalent
Brighton, MA1 day ago- ...years professional experience in legal, regulatory, compliance environments; attorneys with... ...actionBuilds trust-based relationships with senior leaders within and outside of the team;... ...managing concerns.Your role reports to the Director of Ethics in Allegations Management.SeniorApprenticeshipWork at office
$146.4k - $334.31k
...in our culture because it is an investment in our people, our future, and what we stand for as a firm.KPMG is currently seeking a Senior Manager to join our International Tax practice. Responsibilities:Coordinate with internal client service teams to assist multinational...SeniorLocal area$92.48k - $160.29k
...distribution channels, legal entities, and strategic initiatives.The Senior Compliance Manager partners closely with business stakeholders... ...provide practical compliance guidance, identify and mitigate regulatory risks, and support adherence to applicable laws, regulations,...SeniorFull timeTemporary workLocal areaFlexible hours$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for... ...senior management on status of global Regulatory Affairs strategies and tactics, procedures and practicesLeads the...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- ...$170kJob Description An established organization is seeking a Senior Compliance Manager to support and drive compliance initiatives... ...processes, systems, and operations align with industry standards and regulatory requirements. This hands on position partners with cross...SeniorFlexible hours
$245k - $300k
...Job Description Job Description Description: Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision... ...Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory...SeniorLocal areaMerida Biosciences
Cambridge, MAa month ago$157k - $173k
...For more information, please visit avalynpharma.com and follow the company on LinkedIn. Position Summary: The Senior Manager, Regulatory Affairs will support the development and execution of the global regulatory strategy and execution for Avalyn's development-stage...SeniorLocal areaAvalyn Pharma
Boston, MA23 days ago- ...-accepted standards like GxP, ISO 9001, and 21 CFR Part 11. As Senior Compliance Manager, US, you will operate as an independent senior... ...for ensuring TetraScience's products and platform meet the regulatory expectations of the world's largest pharma and biotech customers...SeniorImmediate startFlexible hours
TetraScience
Cambridge, MA4 days ago $212k - $333.19k
...a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$172k - $280.5k
...SUMMARYThis is an outstanding career opportunity for a highly motivated Regulatory Counsel to join the Legal team at Flagship Pioneering. The... ...expectations for in-person attendance will be coordinated with senior management and may be adjusted from time to time based on...SeniorLocal area$225k - $275k
...Great Place to Work in 2026. Description Of Role As the Senior Director, Global Regulatory Strategy you will report to the VP, Regulatory and Medical... .... Lead regulatory sub‑teams and represent Regulatory Affairs on cross‑functional governance and program teams, driving...SeniorFull timeCentessa Pharmaceuticals
Boston, MA36 minutes ago- 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
- ...the specified locations.The Financial and Regulatory Reporting Team function within Schwab... ...additional product types and is looking for a Senior Manager to support their growing team.... ...contributor role and will report to a Director People Leader in the team.Primary...SeniorFull timeWork at office
- Sanofi Inc. is seeking a Senior Manager Regulatory Affairs Advertising and Promotion to lead independent reviews of advertising and promotional materials and help shape regulatory strategies for campaigns. You will serve as the primary FDA liaison for assigned products...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Regulatory Affairs. Be the first to apply!
Related searches
- director global regulatory affairs Waltham, MA
- compliance manager Waltham, MA
- manager regulatory affairs Waltham, MA
- regulatory manager Waltham, MA
- head compliance Waltham, MA
- regulatory affairs director Waltham, MA
- regulatory affairs manager pharmaceutical Waltham, MA
- regulatory & compliance manager Waltham, MA
- compliance director Waltham, MA
- senior operations technician Waltham, MA