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Associate Director, Global Regulatory Affairs
Associate Director, Global Regulatory AffairsOrganon • Jersey City, NJ, US
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Associate Director, Global Regulatory Affairs

Associate Director, Global Regulatory Affairs

Organon • Jersey City, NJ, US
30+ days ago
Job type
  • Full-time
Job description

Global Regulatory Lead

The Associate Director, Global Regulatory Lead (GRL), will be responsible for the development and implementation of worldwide regulatory strategies for projects in their assigned therapeutic area portfolio.

Responsibilities include :

  • Developing regulatory strategies for assigned products to optimize label and obtain shortest time to approval by regulatory agencies.
  • Managing projects within their assigned therapeutic area portfolio.
  • Leading the Global Regulatory Teams to coordinate cross-functional regulatory support.
  • Interacting with worldwide regulatory agencies regarding global regulatory requirements.
  • Covering complex programs with multiple indications, formulations, or external business partners.
  • Coordinating the preparation, submission, and follow-up contact with regulatory agencies.
  • Conducting regulatory review and final approval of all submissions and associated documentation.
  • Providing expertise as the Global Regulatory Lead to Product Development Teams.
  • Communicating new legislations, guidelines, and standards affecting the company's product to other teams.

Additional responsibilities may include :

  • Reviewing and providing final approval of local registration study protocols.
  • Representing the company with external organizations through direct communication with regulatory agencies.
  • Coordinating interactions with foreign agencies and supporting regional colleagues.
  • Reviewing and providing final approval of worldwide marketing applications, clinical study reports, protocols, and confidential investigator brochures.
  • Providing expert advice to Product Development Teams on regulatory issues.
  • Representing Global Regulatory Affairs within internal committees.
  • Participating in regulatory due diligence activities for licensing candidate review.
  • Acting as mentor for Sr Scientist for specific projects.

    • Other tasks include :

  • Participating in projects outside of current responsibilities.
  • Contributing to solutions and managing day-to-day operational issues.
  • Providing education, training, and advice to ensure compliance.

    • Competencies include :

  • Developing and managing worldwide regulatory strategies.
  • Regulatory product and compliance management.
  • Good verbal and written communications.
  • Knowledge of regulatory regulations and guidance.
  • Intermediate understanding of the therapeutic area.
  • Superior interpersonal skills.
  • Proven track record of critical, strategic, independent thinking.
  • High level of motivation and demonstration of leadership values.

    • Required Education, Experience, and Skills :

  • B.S. or M.S. with 5 years relevant drug development experience, a majority of which should be in Regulatory.
  • Ph.D., Pharm. D., or M.D. with 3 years relevant drug development experience, preferably with 3 years in Regulatory.
  • Regulatory experience with a broad therapeutic area, preference for experience with dermatology or women's health.
  • Demonstrated scientific knowledge, writing ability, effective communication, and thorough familiarity with worldwide regulatory agencies, especially US-FDA and EU regulations.
  • Outstanding interpersonal, communication, and negotiation skills.
  • Demonstrated leadership attributes; experienced at building and leading high-performing teams.
  • Fluency in English (written and spoken).
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    Associate Regulatory • Jersey City, NJ, US

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