Regulatory Affairs Director - Pharmaceutical


Jersey City, NJ

Industry: Biotech/Pharma


11 - 15 years

Posted 422 days ago

  by    Nancy Christie

This job is no longer available.

Regulatory Affairs Director – Pharmaceutical

Our client is a global leader in pharmaceutical solutions providing prescription products across multiple call points. They are seeking to hire a Regulatory Affairs Director responsible for managing the creation and review of filings for new generic drugs and monitoring the activities and submissions of new products. The role also manages the labeling process including the creation and implementation of labeling and the regulatory requirements associated ensuring compliance.


•     Monitor the creation, review, evaluation and submission of new drug filings/applications and reports in compliance of FDA submissions and drug filing regulations (U.S. & International)

•     Oversee Chemistry team; ensure projects are completed within deadline and respond to deficiencies

•     Manage post-marketing activities; Supplements submission, reporting, drug listing, etc.

•     Review product development reports and provide regulatory guidance

•     Maintain comprehensive electronic lists for deficiencies

•     Ensure prototype formulation compliance with Inactive Ingredient Database and provide CMC requirements guidance

•     Liaison for customs release inquiries and detained shipment releases

•     Review/update Standard Operating Procedures for CMC, labeling and filing

•     Create and review FDA submission documentation of SPL conversion of labeling

•     Monitor labeling filings, prepare new submissions and provide strategies

•     Manage label creation process/procedures; review and implement all labeling

•     Ensure company compliance and fulfillment of regulatory requirements in relation to labeling

•     Collaborate with regulatory agencies/groups for development of labeling


•     Bachelor’s Degree

•     Master’s Degreepreferred

•     Min. 10+ years’ experience in Pharmaceutical Regulatory CMC and Labeling

•     Previous experience within generic pharmaceutical industry

•     Knowledge/Understanding of regulatory guidance, CFR, USP and ICH

•     Previous RA labeling experience strongly preferred

•     Knowledge/Understanding of drug development and post approval maintenance

•     Knowledge/Understanding of Chemistry batch records

•     Ability to prioritize & multi-task, ability to work collaboratively

•     Strong communication & project management skills

•     Advanced computers skills required


•     Base Salary $120,000 - $150,000 (based on experience)

•     Bonus Potential

•     Full Benefits Package: matching 401K

•     Relocation Package available

Any information contained in this email is subject to change. Please review compensation package with the client at the appropriate time. Interviews are not an indication that an offer will be made. All offers given by our clients are contingent on a thorough background check Direct SalesRecruiting, LLC, (DSR) and DirectHR are National Recruitment organizations partnering with National, Regional and Local Clients to bring qualified candidates a career and a future. DSR offers over 50 years combined Recruitment, Sales and Management experience. We are, along with our clients, an Equal Opportunity Employer and are committed to hiring and supporting a diverse workforce. AM/F/D/V 

$138K - $172K