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Miles
Km80.5

Senior Director Regulatory Affairs

Omega Management Group

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Location: Central NJ, NJ Posted Date: 4/9/2013 Position Type: Full time Job Code: 5046 Required Education: Bachelors Degree

Description

The Sr. Director Regulatory Affairs is responsible for the strategy, oversight and leadership for all regulatory aspects of assigned product within the portfolio. S/he will directly manage the assigned product(s) by partnering with Regulatory Operations, Project Management, Core/Product teams and outside vendors to ensure timely submission of all Regulatory documents to Health Authorities. The Sr. Director, Regulatory Affairs will be the principal contributor for any health authorities’ inspections, as requested by the Quality Department. In addition, this position will be responsible for supporting the global product lifecycle activities, including the submission and maintaining of CTAs (ex-US IND activities) and market registration applications.
Key Accountabilities
•   Proactively provide Regulatory guidance and strategy to Core/Product team.
•   Devise Regulatory strategy to ensure successful interactions and submissions with regulatory authorities which are aligned with goals.
•   Regulatory Lead for assigned products at all external meetings.
•   Partner with internal departments to assure that their respective issues and plans align with regulatory requirements and guidance for assigned product(s).
•   Ensuring that all appropriate personnel is kept informed to allow for efficient and rapid decision making.
•   Ensure quality and timely submission filings, with documentation of application risks.
•   Work with the team to define path for timely approval of pipeline products at various stages of development (eg., IND/CTA, BLA/NDA).
•   Ensures the preparation, quality and timeliness of relevant sections of assigned projects submissions, Annual Reports…etc.
•   Working with Pharmacovigilance department in submission risk assessment process.
•   Provides regulatory review of all regulatory submission documents for assigned products.
•   Responsible for the development and maintenance of Regulatory Affairs’ SOPs.
•   Supporting Marketing and Medical Affairs for Post-Approval regulatory needs.
•   Serve as backup for other RA Product Directors as needed.

Requirements

Education: a minimum of a BS degree in science, advanced degree desired
Experience:
•   10+years’ of experience within Regulatory Affairs.
•   Demonstrated and current hands-on capabilities for multiple CTAs/INDs, and BLAs/NDAs submissions
•   Experience with Advisory Committee hearings a plus
Specific skills: Knowledge of Food & Drug Law, regulations and guidance. Ability to articulate regulatory position concisely. Excellent verbal and written skills, including writing submission sections. MS Office Suite of products.
Specialized knowledge, Licenses, etc.: RAC desired but not required
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