PTS Advance is currently hiring for a Manager of Regulatory Affairs- Pharmaceuticals for our globally leading CRO client based on the East Coast.

In this role you would be responsible for implement strategies to support multiple leading Pharmaceutical clients for various regulatory activities.

Duties & Responsibilities:

• Provide strategic and tactical leadership of the regulatory affairs function in collaboration with cross functional teams.
• Effectively collaborate with global leadership to seek out new opportunities for growth both with current clients and new clients.
• Act as SME with deep knowledge of FDA regulations for all aspects of Pharmaceuticals regulations. Collaborate with internal staff to author and compile documents for submission to regulatory agencies, including INDs, CTAs, BLAs, MAAs, and NDAs.
• Provide consulting services within personal area of expertise this could include submission writing, conducting final reviews, and/or meeting with regulatory agencies on client's behalf.

The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike.

Qualifications:

• Bachelor's or master's degree in a scientific field.
• At least 4+ years of Pharmaceutical regulatory experience with a background in dealing with the FDA and international regulatory authorities.
• Experience in all aspects of regulatory affairs including CMC, Clinical, and post market commitments.
• Experience with submission writing such as INDs, MAAs, NDAs, BLAs, etc.
• Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details

If you are someone you know may be interested, please send your resume to Allison.Sudman@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role.

#LifeSciences #PTSAdvancejobs #PTSAdvance