Associate Director/Director Regulatory Affairs

Location
Princeton, New Jersey
Posted
Feb 26, 2018
Ref
5065
Required Education
Bachelors Degree
Position Type
Full time

Associate Director/Director Regulatory Affairs

The Associate Director/Director, Regulatory Affairs is responsible for the implementation of the regulatory strategy, under the direction of the SVP, Regulatory Affairs, to secure and maintain access for the company products through all development phases and through post-approval life-cycle management.

Responsibilities

  • Collaborate with VP, Regulatory Affairs to define and execute regulatory strategies to ensure product approvals consistent with corporate objectives and applicable regulations and guidelines.
  • Represents Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings
  • Supports planning and execution of major submissions and responses to regulatory authorities related to INDs, amendments, aggregate reports, NDAs and supplements within company timelines and in accordance with regulations and guidelines.
  • Determines innovative and sound strategies in support of submission goals.
  • Interacts and manages internal/external functional business units effectively to gather data and develop documentation required for on-time submissions.
  • Ensures submission documents are accurate, compliant, and high-quality to allow for smooth and rapid approvals from regulatory authorities.
  • Develop and maintain relationships with FDA review staff; assist with the management/conduct of regulatory interactions with FDA, assuring that interactions are focused, amicable and documented.
  • Monitor the regulatory landscape for competitive products and apply this knowledge to the development of products.
     

Qualifications

EXPERIENCE:

  • 7+ years of relevant experience in pharmaceutical R&D industry and/or regulatory affairs.
  • Hands-on experience in gaining regulatory approval on at least one major marketing application (NDA/BLA/MAA/JNDA etc. or major supplemental application) or strategic lead experience with late stage/marketed products/ life-cycle management.

EDUCATION:

  • Minimum of a Bachelor's degree with 5+years of regulatory experience.  Master’s Degree or higher with an emphasis on health related/life sciences preferred