Director, Global Regulatory Affairs Strategy-Biotech/Pharmaceutical

Location: Northern NJ, NJ
Date Posted: 10-18-2016
Job Description :

The Director, Global Regulatory Affairs is responsible for directing all regulatory activities from preclinical development through filing of marketing applications and post-approval activities. The Director leads the efforts to obtain worldwide approvals to market products and provides ongoing regulatory support for commercial products.

• Develops and implements strategic regulatory plans for clinical manufacturing and preclinical programs.
• Ensures compliance with FDA/ICH regulations and guidelines related to preclinical and clinical, regulatory submissions, product launch, labeling, and promotional activities.
• Directs regulatory activities pertaining to Health Authority meetings and negotiations.
• Works closely with development teams, by providing guidance and technical input.
• Provides regulatory support to the business development activities to review potential licensing candidates.
• Reviews responses to inquires from regulatory agencies.
• Responsible for identifying and maintaining a network of external regulatory consultants to assist internal staff with meeting regulatory goals and timelines.
• Develops and implements strategies for the most efficient regulatory filings.
• Responsible for all aspects of US, EU and rest-of-world regulatory filings and post-approval regulatory activities.

• Bachelor’s degree in scientific or life sciences discipline or related required.
• Advanced degree in scientific or life sciences discipline or related (e.g., PharmD, PhD, MD) strongly preferred.
• Minimum of 10+ years of progressive leadership in regulatory affairs in the biotech/pharmaceutical industry is required.
• Direct responsibility for NDA filing(s) in the US preferred.
• Strong understanding of US and international pharmaceutical guidelines and regulations is required experience in establishing and delivering on European and other international regulatory strategies strongly preferred.
• Experience and/or knowledge of inflammation and immunology therapeutic area.
• Expert knowledge of FDA and EMEA.
• Ability to build and foster relationships.
• Decisive and proactive with hands-on, can-do style and attitude and the ability to prioritize are critical for success.
• Ability to serve as team leader on interdepartmental teams.
• Excellent writing, communication, presentation, skills.
• Demonstrated leadership and project management skills.
• Strong interpersonal and negotiation skills.
• Proven ability to manage multiple projects in a fast paced environment.
Candidate Must Have : Bachelor degree,Direct interaction with FDA,Global Regulatory Affairs Strategy for Clinical Development,NDA experience,Hands-on approach and Strong Leadership Gravitas
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

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