Associate Director - Regulatory Affairs/ Medical Writting

---

Job description

Role: Associate Director - Regulatory Affairs
Location: Remote
Duration: Long Term Contract
Job Description
The Associate Director in Regulatory Project Management will be responsible for the coordination, prioritization, and tracking of regulatory activities and submissions associated with the company's research, development, and post-marketing activities for a variety of therapeutic areas. Regulatory activities may include support for both products in early and late-stage development and marketed products.
Essential Duties and Job Functions

• The Associate Director in Regulatory Project Management will develop and maintain detailed timelines for global regulatory activities and submissions for assigned therapeutic areas in the US, EU, and Japan, and ensure planning and coordination of activities via the Regulatory Submission Team.
• The Associate Director in Regulatory Project Management will foster effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.
• Ensuring regulatory submissions are prepared according to defined Corporate or Regulatory timelines
• Working with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.

- provided by Dice