Director, Regulatory Affairs
New
This role is remote-friendly, with most work conducted from home.Full-TimeDirector
SalaryNew York City, Boston, & San Francisco Bay Area(s): $228,250–$280,720; Salt Lake City & all other U.S. locations: $207,500–$255,200
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Job Details
- Experience
- Minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs.
- Required Skills
- Cross-functional Team Leadership
Requirements
- Minimum of 10 years in the pharmaceutical industry.
- Minimum of 8 years in Global Regulatory Affairs.
- Experience with major Health Authorities (US FDA, Health Canada, UK MHRA, and EMA).
- Minimum of 8 years experience with regulatory submissions including INDs, NDA/NDS/MAA, and post-marketing measures.
- Experience with Paediatric Investigation Plans (PIP/PSP) and Orphan Drug Designation (ODD).
- Familiarity with Breakthrough Designation (BTD) and EU PRIME activities.
- Strong understanding of regulatory strategy and operational implementation.
- Outstanding management, interpersonal, communication, and negotiation skills.
- Demonstrated proficiency in organizational awareness and cross-functional global teamwork.
Responsibilities
- Manage regulatory strategy and activities for global development of products through all stages of development and post-approval.
- Participate in global product team meetings to provide regulatory support and guidance.
- Coordinate multiple projects simultaneously while assessing immediate and long-term regulatory risks.
- Create and implement regulatory execution procedures for clinical trial applications, marketing authorization applications, and designation applications.
- Collaborate with clinical, commercial, and medical affairs functions to provide regional regulatory insights.
- Serve as the point of contact with relevant Health Authorities and lead interactions with external stakeholders.
- Review and interpret regulatory guidelines and create communication plans for internal distribution.
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