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Senior Director/ Executive Director Regulatory Affairs CMC

Company: Hamlyn Williams
Location: New Brunswick
Posted on: February 21, 2021

Job Description:

A global Pharmaceutical organization is looking to hire a Sr. Director or Executive Director, Regulatory Affairs CMC to join the New Jersey Office's Regulatory Affairs function. The role will report to the VP Regulatory Affairs and will have director reports.Key Responsibilities* Responsible for the RA CMC strategic leadership to support a wide variety of therapeutic areas and dosage forms both within small molecule and biologics indications* Responsible for direct reports, leading, mentoring and developing a team of junior to mid-level regulatory CMC professionals* Manage and implement submissions of CMC related applications with a focus on the US and EU/EMEA region* Ensure that CMC sections (including IMPDs/INDs, MAAs or BLAs) are complete* Collaborate effectively with Regulatory Strategy Leads, coordinate negotiations on CMC topics--with regulatory agencies to resolve CMC issues* Effectively communicate regulatory CMC strategies to the VP Regulatory Affairs and other cross-functional teams* Assesses the impact of new regulations, guidances or enforcements and advise the Regulatory Group on requirements to maintain compliance with regulatory operations activities.Minimum Qualifications* M.S. degree in biochemistry, chemistry, biology, Ph.D. is desireable* 10+ years of relevant biopharmaceutical industry experience, with 8+ years experience in CMC-focused Regulatory Affairs with at least 5+ years of experience in biologics.Apply here or email if you are interested in working with a--leader in the biopharma space.

Keywords: Hamlyn Williams, New Brunswick , Senior Director/ Executive Director Regulatory Affairs CMC, Executive , New Brunswick, New Jersey

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