Senior Director/ Executive Director Regulatory Affairs CMC
Company: Hamlyn Williams
Location: New Brunswick
Posted on: February 21, 2021
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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
r.burton@hamlynwilliams.com 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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