Director Regulatory Affairs
2 weeks ago
Director of Regulatory Affairs Strategy
This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development.
Key Responsibilities:
- Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence.
- Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts.
- Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities.
- Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents.
- Support due diligence activities for potential product acquisitions or partnerships.
- Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings.
- Monitor the regulatory landscape and communicate updates to stakeholders.
- Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues.
Qualifications:
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Minimum 10 years of experience in pharmaceutical regulatory drug development.
- Proven track record in new chemical entity and line extension filings.
- Experience interacting with global health authorities and conducting due diligence.
- Strong knowledge of global pharmaceutical regulations and excellent communication skills.
-
Director, Regulatory Affairs, US
1 week ago
Philadelphia, United States SERB Pharmaceuticals Full timeCome and Save Lives with Us!SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 470 employees in 16 countries and a group revenue in excess of €350m.Our portfolio 80+ rescue...
-
Director Regulatory Affairs
2 weeks ago
Philadelphia, United States EPM Scientific Full timeDirector of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with...
-
Director Regulatory Affairs
1 month ago
Philadelphia, United States EPM Scientific Full timeJob DescriptionJob DescriptionDirector of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health....
-
Regulatory Affairs Director CMC
4 weeks ago
Philadelphia, Pennsylvania, United States i-Pharm Consulting Full timeOverviewWe are seeking a skilled Associate Director with expertise in CMC Regulatory to join our team. This role offers a unique blend of a supportive environment and high visibility within a global leader in the pharmaceutical industry.About the RoleThis position involves developing and implementing tailored CMC regulatory strategies for specific countries....
-
Senior Director, Global Regulatory Affairs CMC
4 weeks ago
Philadelphia, United States Adaptimmune Full timeAdaptimmune is a fully integrated commercial-stage cell therapy company, designed and built from the ground up with UK- and U.S.-based biotechnology hub locations. In the U.S., locations are in Cambridge, MA and Philadelphia, PA. In the UK, locations are in Oxford and Stevenage. Our comprehensive capabilities and teams include preclinical research, clinical...
-
Sr. Regulatory Affairs Specialist
2 days ago
Philadelphia, United States Proclinical Staffing Full timeSr. Regulatory Affairs Specialist - Contract - Philadelphia, PAProclinical is seeking a Senior Regulatory Affairs Specialist to join a dedicated team. Primary Responsibilities:The successful candidate will work independently on complex protocols, review and create core documents, and prepare health authority submissions. You will facilitate communications...
-
Senior Director, Global Medical Affairs
4 weeks ago
Philadelphia, United States EPM Scientific Full timeWe are seeking a highly skilled and experienced Senior Director, Global Medical Affairs (Oncology) to lead and develop our oncology medical affairs strategy on a global scale. The ideal candidate will possess a strong scientific background exceptional leadership abilities, and extensive knowledge of oncology therapeutics and clinical development. This role...
-
Senior Director, Global Medical Affairs
4 weeks ago
philadelphia, United States EPM Scientific Full timeWe are seeking a highly skilled and experienced Senior Director, Global Medical Affairs (Oncology) to lead and develop our oncology medical affairs strategy on a global scale. The ideal candidate will possess a strong scientific background exceptional leadership abilities, and extensive knowledge of oncology therapeutics and clinical development. This role...
-
Senior Director, Global Medical Affairs
4 weeks ago
philadelphia, United States EPM Scientific Full timeWe are seeking a highly skilled and experienced Senior Director, Global Medical Affairs (Oncology) to lead and develop our oncology medical affairs strategy on a global scale. The ideal candidate will possess a strong scientific background exceptional leadership abilities, and extensive knowledge of oncology therapeutics and clinical development. This role...
-
Senior Director, Global Medical Affairs
4 weeks ago
Philadelphia, United States EPM Scientific Full timeJob DescriptionJob DescriptionWe are seeking a highly skilled and experienced Senior Director, Global Medical Affairs (Oncology) to lead and develop our oncology medical affairs strategy on a global scale. The ideal candidate will possess a strong scientific background exceptional leadership abilities, and extensive knowledge of oncology therapeutics and...
-
Associate Director CMC Regulatory
4 weeks ago
Philadelphia, United States i-Pharm Consulting Full timeAre you a Senior Manager or Associate Director with expertise in CMC Regulatory seeking a long-term career home? *APPLY BELOW*Join a global leader in the pharmaceutical industry known for its people-first culture, dedication to volunteerism, and commitment to philanthropy! This role offers a unique blend of a supportive, close-knit environment within the...
-
Associate Director CMC Regulatory
4 weeks ago
philadelphia, United States i-Pharm Consulting Full timeAre you a Senior Manager or Associate Director with expertise in CMC Regulatory seeking a long-term career home? *APPLY BELOW*Join a global leader in the pharmaceutical industry known for its people-first culture, dedication to volunteerism, and commitment to philanthropy! This role offers a unique blend of a supportive, close-knit environment within the...
-
Associate Director CMC Regulatory
4 weeks ago
philadelphia, United States i-Pharm Consulting Full timeAre you a Senior Manager or Associate Director with expertise in CMC Regulatory seeking a long-term career home? *APPLY BELOW*Join a global leader in the pharmaceutical industry known for its people-first culture, dedication to volunteerism, and commitment to philanthropy! This role offers a unique blend of a supportive, close-knit environment within the...
-
Senior level regulatory consultant
1 week ago
Philadelphia, United States Proclinical Staffing Full timeSenior Level Regulatory Consultant - Contract - PhiladelphiaProclinical is working alongside a biotech seeking a Senior Level Regulatory Consultant to join the team. In this role, you will provide strategic input and day-to-day guidance for assigned projects within the oncology and medical devices sector. You will work closely with cross-functional teams and...
-
Senior Manager Regulatory Affairs
1 week ago
Philadelphia, United States HIRESIGMA Full timeExperience you will need:Bachelor’s degree with 7 years of regulatory experience or Master’s degree with 5 years of regulatory experienceExperience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for Premarket Approval (PMA) for Class...
-
Regulatory and Accreditation Specialist
2 months ago
Philadelphia, United States Temple University Full timeIdentifies process improvement opportunities and leads, manages and executes Regulatory and Accreditation projects from conception through completion under the direction of the Chief Regulatory Affairs Officer. Identifies opportunities in data, develops education and streamlines policy as indicated by Regulatory and Accreditation requirements. This position...
-
philadelphia, United States Proclinical Staffing Full timeSenior Level Regulatory Consultant - Contract - PhiladelphiaProclinical is working alongside a biotech seeking a Senior Level Regulatory Consultant to join the team. In this role, you will provide strategic input and day-to-day guidance for assigned projects within the oncology and medical devices sector. You will work closely with cross-functional teams and...
-
Clinical Research Regulatory Specialist A
1 month ago
Philadelphia, United States DirectEmployers Full timeUniversity OverviewThe University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U. S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for...
-
Associate Director of Drug Product CMC
4 weeks ago
philadelphia, United States EPM Scientific Full timeAssociate Director, Drug Product CMCGreater Philadelphia Area HybridJob Summary:The Associate Director of Drug Product CMC leads and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to...
-
Associate Director of Drug Product CMC
4 weeks ago
philadelphia, United States EPM Scientific Full timeAssociate Director, Drug Product CMCGreater Philadelphia Area HybridJob Summary:The Associate Director of Drug Product CMC leads and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to...