Current jobs related to Regulatory Strategy Manager - Cambridge, Massachusetts - Moderna Therapeutics
-
Director of Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob OpportunityThe Role:Moderna is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRNA vaccines. This role is intended for a forward-thinking, creative regulatory strategist able to anticipate and address challenges in clinical development and gain market approval for mRNA vaccines.The Director will be a strategic leader...
-
Director of Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced Director of Regulatory Strategy to join our team at Intellia Therapeutics, Inc. As a key member of our Regulatory Affairs group, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global health authorities.Key ResponsibilitiesDevelop and implement...
-
Director of Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob DetailsThe Role:Moderna is seeking a seasoned professional to lead the development and implementation of global regulatory strategy for its Latent Viruses mRNA vaccines. The ideal candidate will have a strong background in regulatory affairs, with a focus on vaccine development and a proven track record of success in navigating complex regulatory...
-
Director of Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob DetailsThe Role:Moderna is seeking a seasoned professional to lead the development and implementation of global regulatory strategy for its Latent Viruses mRNA vaccines. The ideal candidate will have a strong background in regulatory affairs, with a focus on vaccine development and a proven track record of success in navigating complex regulatory...
-
Director of Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeTransforming Lives through Gene EditingAt Intellia, we're pioneering a new era in genome editing. As a key member of our Regulatory Affairs team, you'll play a crucial role in shaping the future of biopharmaceutical development. About the Role:We're seeking a seasoned regulatory expert to lead our registration programs and drive strategic decision-making. As...
-
Associate Director Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeAssociate Director of Regulatory StrategyAgios Pharmaceuticals is seeking an experienced Associate Director of Regulatory Strategy to join our growing Regulatory team. As a key member of our team, you will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the...
-
Associate Director Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeRole SummaryAgios Pharmaceuticals is seeking an Associate Director of Regulatory Strategy to join our growing Regulatory team. This role will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.Key ResponsibilitiesDevelop and execute global...
-
Director of Global Regulatory Strategy
1 week ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob DetailsThe Role:As a key member of our Global Regulatory Science team, we are seeking a Director of Global Regulatory Strategy to develop and lead the global strategy for our mRNA vaccine programs. The ideal candidate will have a strong background in regulatory strategy, particularly in vaccine development, and will be able to articulate clear and...
-
Associate Director of Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob DetailsThe Role:Moderna Therapeutics is seeking a seasoned regulatory professional to support the development and registration of oncology therapeutics and vaccines based on messenger RNA technology. This role requires a forward-thinking, creative, and agile individual who can anticipate and address regulatory challenges in the US and ex-US markets.The...
-
Associate Director Regulatory Strategy
2 weeks ago
Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full timeAbout Intellia Therapeutics, Inc.We are a biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to transform the lives of patients and their families.Job SummaryWe are seeking an experienced Associate Director to lead our Global Regulatory Strategy team. As a key member of...
-
Cambridge, Massachusetts, United States Moderna Full timeThe Opportunity:Moderna is seeking a Director of Regulatory Strategy to lead the development and implementation of global regulatory strategy for our Latent Viruses mRNA vaccines. As a key member of our Global Regulatory Science team, you will be responsible for articulating clear and compelling regulatory strategy, highlighting risks and opportunities, and...
-
Cambridge, Massachusetts, United States Moderna Full timeAbout the RoleModerna Therapeutics is seeking an experienced Associate Director to lead the development and execution of regulatory strategies for the oncology franchise. As a key member of the Global Regulatory Strategy team, you will be responsible for setting the strategic direction for the US market and ensuring alignment with global product strategy.Key...
-
Cambridge, Massachusetts, United States Moderna Full timeAbout the RoleModerna Therapeutics is seeking an experienced Associate Director to lead the development and execution of regulatory strategies for the oncology franchise. As a key member of the Global Regulatory Strategy team, you will be responsible for setting the strategic direction for the US market and ensuring alignment with global product strategy.Key...
-
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob OpportunityAbout the Role:Moderna Therapeutics is seeking a highly skilled Associate Director to lead the development and execution of regulatory strategies for oncology therapeutics. This is a key role within the Global Regulatory Strategy, Oncology group, responsible for articulating clear and compelling regulatory strategies and highlighting risks and...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Massachusetts, United States Ipsen Pharma Full timeJob SummaryAs a Regulatory Affairs Director at Ipsen Pharma, you will be responsible for developing and implementing regulatory strategies for assigned programs and products. You will provide regulatory expertise to R&D, Franchise, and Commercial Operations, and act as the interface between these teams and global regulatory authorities. Your goal will be to...
-
Senior Manager, Regulatory Compliance
4 weeks ago
Cambridge, Massachusetts, United States Moderna Full timeAbout the RoleWe are seeking a highly skilled Senior Manager, Inspection Management, R&D Quality to join our team at Moderna. In this role, you will be responsible for leading the planning, coordination, and execution of regulatory health authority inspections across R&D. You will work closely with cross-functional teams to ensure compliance with health...
-
Regulatory Affairs Strategist
2 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeAt Agios Pharmaceuticals, we're seeking a skilled Regulatory Affairs Strategist to join our growing Regulatory team.This individual will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.The successful candidate will prepare and oversee the...
-
Regulatory Affairs Leader
2 weeks ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timeThe OpportunityWe are seeking a seasoned regulatory affairs professional to join our growing team at Relay Therapeutics. As a strategic regulatory leader, you will play a critical role in defining and implementing innovative regulatory strategies to accelerate the development and approval of our transformative pipeline.You will serve as the global regulatory...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Massachusetts, United States Ipsen Pharma Full timeJob SummaryThe Director of Regulatory Affairs will be responsible for developing and implementing regulatory strategies for assigned programs and products. This includes providing regulatory expertise to R&D, Franchise, and Commercial Operations, as well as serving as the interface between these teams and the Global Regulatory Affairs (GRA) organization.Main...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Massachusetts, United States PSG Global Solutions Careers Full timeAssociate Director Regulatory Affairs CMC Job DescriptionWe are seeking an experienced Associate Director Regulatory Affairs CMC to join our team at PSG Global Solutions Careers. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory CMC strategies for assigned programs.Key Responsibilities:Lead...
Regulatory Strategy Manager
2 months ago
Moderna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in developing and implementing regulatory strategies for our mRNA therapeutics.
Key Responsibilities- Develop and contribute to content, format, and accountability for regulatory submissions and related supplements and amendments.
- Work with RA-Strategist and project teams to develop and execute regulatory strategy through the clinical development process.
- Coordinate aspects of regulatory submissions relevant to assigned projects or programs.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development.
- Contribute to the maintenance of the Core Data Sheet and support global labeling team meetings.
- BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
- 5+ years of experience in the Pharmaceutical industry preferred.
- 3+ years of experience in Regulatory strategy or relevant training/experience preferred.
- Experience in Oncology is strongly preferred.
- Strong knowledge of current US and EU regulations.
- Strong experience with CTD format and content of regulatory filings.
- Exceptional written and oral communication skills.
- Experience with developing and implementing gap analysis and related competitive regulatory strategies.
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance.
- Base compensation for this position in Washington State ranges from $125,500 to $201,000.
- A comprehensive incentive compensation package, including an annual cash bonus, new hire equity, and an annual refresh.
- A 401(k) match and financial planning tools.
- Competitive and inclusive medical, dental, and vision coverage options.
- Flexible spending accounts for medical expenses and dependent care expenses.
- Lifestyle spending account funds to help you engage in personal enrichment and self-care activities.
- Family care benefits, including subsidized back-up care options and on-demand tutoring.
- Free premium access to fitness, nutrition, and mindfulness classes.
- Exclusive preferred pricing on Peloton fitness equipment.
- Adoption and family-planning benefits.
- Dedicated care coordination support for our LGBTQ+ community.
- Generous paid time off, including vacation, sick time, and holidays.
- Discretionary year-end shutdown.
- 18 weeks of 100% paid parental leave for all new parents.
