- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... registration and life cycle support and the leadership of regulatory strategy for projects that are currently US...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders… more
- Eisai, Inc (Nutley, NJ)
- …consider remote based.Eisai Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs , Growth Markets is from ... broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration...the employment eligibility of all new hires in the United States . Please click on the following… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... development, regulatory , and registration strategies within the US and Canada. The Director will also...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Post Holdings Inc. (Lakeville, MN)
- …about pet nutrition and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs ** , where you'll lead a ... FDA standards. + Oversee **product registration and certification** across US states and manage import/export regulatory...years of experience in pet food, food science, or regulatory affairs . + Proven leadership experience managing… more
- Merck & Co. (Rahway, NJ)
- … Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner ... Management, Employee Training Programs, FDA Regulations, Life Science, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Policy Implementation, Regulatory… more
- Insmed Incorporated (NJ)
- …experience in Regulatory Affairs , with hands-on experience in regulatory submissions across multiple regions ( US , EU, and/or other international ... prepared by other technical functions and will act as the primary regulatory contact for the US FDA. The GRL will be accountable for regulatory submissions,… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …THIS IS A REMOTE BASED OPPORTUNITY IN THE UNITED STATES The Director , Global Medical and Promotional Regulatory Affairs will be a member of ... Jazz Pharmaceuticals' Global Medical and Promotional Regulatory Affairs group and will be assuming...assigned products in oncology or assigned therapeutic area. The Director works autonomously and collaboratively with Regulatory ,… more
- GRAIL (Durham, NC)
- …position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, ... projects, including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs),… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive… more
