Current jobs related to Executive Director, Regulatory Affairs Specialist - San Diego, California - Travere Therapeutics
-
Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Codera Full timeJob Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...
-
Regulatory Affairs Director
3 weeks ago
San Diego, California, United States Codera Full timeJob Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...
-
Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Gossamer Bio Full timeJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gossamer Bio. As a Director / Senior Director, CMC Regulatory Affairs, you will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination...
-
Executive Director
2 weeks ago
San Francisco, California, United States NextEra Energy , Inc. Full timeJob SummaryNextEra Energy, Inc. is seeking an Executive Director - Regulatory Affairs to lead our regulatory affairs efforts in the West Region. This role will be responsible for overseeing all regulatory affairs activities, including policy coordination, stakeholder engagement, and regulatory proceedings.Key Responsibilities:Develop and implement regulatory...
-
CMC Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Gossamer Bio Full timeJob SummaryThe Director/Senior Director, Regulatory Affairs will lead the development and execution of innovative CMC regulatory strategies to support the global development and commercialization of a drug/device combination product. This role requires dynamic leadership and direction to multi-disciplined project teams, working collaboratively with...
-
Regulatory Affairs Director
4 weeks ago
San Diego, California, United States CorDx Full timeJob Title: Associate Director of Regulatory AffairsCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.Key Responsibilities:Prepare and submit regulatory...
-
Regulatory Affairs Specialist
7 days ago
San Diego, California, United States Neurocrine Biosciences Full timeJob Title: Regulatory Affairs Specialist - CMCNeurocrine Biosciences is seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and execution of regulatory strategies for assigned commercial and development projects.Key...
-
Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Ignite Human Capital Full timeCompany Overview: Ignite Human Capital is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer.Position Overview: We are seeking an accomplished and dynamic Senior Director of Regulatory Affairs...
-
Regulatory Affairs Specialist
1 month ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...
-
Regulatory Affairs Specialist
3 weeks ago
San Diego, California, United States Tandem Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Prepare and maintain domestic and international regulatory...
-
Regulatory Affairs Specialist
1 month ago
San Diego, California, United States Bayside Solutions Full timeJob Title: Regulatory Specialist, R&DJob Summary:We are seeking a highly skilled Regulatory Specialist to join our R&D team. As a key member of our team, you will be responsible for implementing worldwide regulatory programs for developing and marketed products, interacting with regulatory authorities to expedite approvals, and providing regulatory expertise...
-
Regulatory Affairs Director
6 days ago
San Diego, California, United States CorDx Full timeJob OverviewCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.This role will play a crucial part in the successful approval and launch of our medical...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States Ajinomoto Bio-Pharma Full timeRegulatory Affairs SpecialistAjinomoto Bio-Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing support for all internal and external regulatory-related activities.Key Responsibilities:Collaborate with internal team members to maintain compliance with...
-
Associate Director Regulatory Affairs
4 weeks ago
San Diego, California, United States BioSpace, Inc. Full timeJob Title: Associate Director Regulatory AffairsAt BioSpace, Inc., we are seeking an experienced Associate Director Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for establishing regulatory strategies and plans, communicating with internal stakeholders, and ensuring compliance with...
-
Senior Director of Regulatory Affairs
2 weeks ago
San Diego, California, United States Ignite Human Capital Full timeJob OverviewIgnite Human Capital is seeking a seasoned Senior Director of Regulatory Affairs to spearhead regulatory strategies and activities concerning the development and approval of cell therapy products.This pivotal role will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives.Key...
-
Regulatory Affairs Specialist
7 days ago
San Diego, California, United States CorDx Full timeAt CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.The ideal candidate will have a strong understanding of regulatory...
-
Regulatory Affairs Specialist
7 days ago
San Diego, California, United States Dexcom Full timeAbout the Role:Dexcom is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a Regulatory Affairs Specialist, you will play a critical role in preparing, submitting, and gaining regulatory approvals for our life-changing products, therapies, and customers around the world.Key...
-
Associate Director Regulatory Affairs
2 weeks ago
San Diego, California, United States BioSpace, Inc. Full timeJob Title: Associate Director Regulatory AffairsAt Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics.The OpportunityThe Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with...
-
Regulatory Affairs Director
2 weeks ago
South San Francisco, California, United States Synectics Full timeJob Title: Regulatory Affairs Associate Director/DirectorJoin Synectics, a leading pharmaceutical company, as a Regulatory Affairs Associate Director/Director and take on a challenging role in shaping the future of oncology drug development.Responsibilities:Develop and implement global regulatory strategies to support the development of multiple oncology...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of...
Executive Director, Regulatory Affairs Specialist
2 months ago
We are seeking a highly experienced and skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. This is a key leadership role that will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.
Key Responsibilities- Develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.
- Lead the development of accelerated global regulatory approval strategies using novel endpoints, biomarkers, or alternative clinical trial data.
- Manage interface with outside regulatory agencies and trade associations.
- Prepare, submit, and maintain product-specific dossiers (IND/CTA, NDA/MAA, and others) per local country requirements with relevant health authorities.
- Negotiate with regulatory authorities and respond to regulatory authority queries during the development and review process.
- Ensure compliance with product post-marketing approval requirements.
- Ensure labeling, publications, advertising, and promotional items are compliant with regulatory requirements.
- Assess regulatory impacts associated with changes made in the development of products.
- Collaborate with internal stakeholders (Medical, Clinical, preclinical) and project leadership teams to define or develop and obtain registration documents as required to support global development actions.
- Provide leadership with global regulatory strategy teams to ensure development of team members through the sharing of knowledge and expertise on strategic thinking and regulatory precedence reviews.
- Ensure regulatory tools are compliant and kept up to current standards.
- Participate in product development and acquisition assessment teams to evaluate potential regulatory strategies.
- Formulate department procedures as required.
- Recruit, develop, and manage an effective regulatory team and elevate the leadership capabilities both via direct and indirect reporting structure to foster and create a goal-oriented culture.
- Build partnerships with senior key stakeholders from other functions to ensure strategic business goals are met through the sharing of knowledge and expertise.
- Bachelor's degree in a scientific discipline. Master's degree preferred. Equivalent combination of education and applicable job experience may be considered.
- 12+ years of increasing Regulatory Affairs experience and responsibility, including proven success with product registrations, rare disease development highly desirable.
- 6+ years of supervisory/management experience in biotech or pharmaceutical industry.
- Demonstrated track record of successful approvals from a major regulatory agency is required. Prior regulatory agency liaison experience is essential.
- Demonstrated experience in both Regulatory Strategy development as well as associated Regulatory tactical and operational activities.
- Experience with portfolio management and program prioritization.
- Advertising and promotional labeling experience is required.
- Excellent written and communication and interpersonal skills and proven success working in a multi-functional team-based environment.
- Strong expertise and knowledge of the drug development process is required. Experience in biologics, drug safety, pharmacovigilance, and/or risk management preferred.
- Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
- Strong influencing and negotiation skills.
- Ability to function effectively in a global scientific and cultural arena.
- Demonstrate leadership capacity managing multiple projects and complex timelines in a highly matrixed team environment by interacting effectively with internal departments and external organizations.
- Excellent team management skills, ability to lead, manage complexity/change, time-sensitive project plans, budgets, train, and coach/mentor team members at all levels.
- Works independently under general supervision. Exercises judgment within generally defined practices and policies.
- Ability to travel 15-20% domestic and internationally.
