This is a pharmaceutical company that provides topical and other specialty therapeutics.
Position Title: Pharmaceutical Regulatory Affairs Manager — 2209-5815
Therapeutic Area: Dermatology
The company seeks an experienced Regulatory Affairs Manager who will build and execute regulatory strategy for post-approval changes to pharmaceutical applications in the US Market.
Essential Duties and Responsibilities
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory, quality, and technical teams.
- Build regulatory strategy for post-approval changes.
- Liaise with FDA and other health authorities, as well as internal and external stakeholders, to inform and execute regulatory submissions.
- Monitor and track information, ensuring accurate communication of the current status of post-approval change control assessments and submissions.
- Review technical documentation and submissions. Recommend/approve changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals.
- Manage a team of regulatory professionals.
Qualifications (Education & Experience)
- Bachelor's degree in a scientific discipline.
- 7-plus years of direct experience in Regulatory Affairs with marketed products, preferable knowledge in sterile products.
- Extensive knowledge in NDA/ANDA/DMF application and lifecycle submissions for US Market.
- Extensive knowledge of FDA/HC/ICH regulations and guidance including knowledge of industry trends for application/supplement preparation.
- Strong leadership skills and management experience.
- Professional interpersonal skills, including the ability to communicate effectively with people both individually and in groups.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.