Regulatory CMC Director >> Lead Global Regulatory CMC Submissions for DD Combination Products >> East Coast or remote, US

Reference: JPC632

Expiry Date: 30-11-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Our team and I are very excited to present you with this brand-new role, working for a large pharma on the East Coast. With a portfolio that earned the company almost 60 billion USD in 2022 and products sold across the globe, the team is constantly expanding and looking for new ways, in which to improve their therapeutics and the way illness is treated.

One of the new roles that our client has is for a Director of Regulatory CMC, implementing Device and Drug-Device Combination (DDDC) regulatory strategies in accordance with domestic and international regulations and guidance.
The right person will be eager to tackle the preparation and submission of combination product sections for commercialization or new products such as pre-filled syringes and autoinjectors. Apart from the implementation of regulatory strategies for assigned projects, the candidate will be expected to provide mentoring, coaching, and leading as required.

Your responsibilities will also include:

  • Being the lead author of CMC strategies regarding submissions, making sure that standards, goals, and timelines are met when it comes to IND/BLA/NDA/MAA
  • Maintaining effective relationships across teams and an up-to-date understanding of global DDDC product requirements and policies concerning all current and future submissions, in order to tackle the various project obstacles that may arise
  • Communicating and aligning with stakeholders on new regulations and requirements to ensure internal procedures and processes are compliant with the assigned products.

Your experience includes:

  • Coming up with innovative solutions to various regulatory problems, demonstrating the necessary flexibility to adapt to changing priorities and events
  • Proven track record liaising with partners and teams and successfully negotiating with the health authorities to achieve desired outcomes
  • CMC regulatory experience, authoring IND/CTA/BLA/MAA with a DDDC.

The role comes with a remote/hybrid working model working EST hours. In addition to the impressive basic salary, the position offers bonus eligibility, health care and other insurance benefits (for employees and family), retirement benefits, paid holidays, vacation, and sick days. 

To apply!

If you are interested in applying or hearing more about this role, please contact me, Theo Moore at 587.216.9302 or my colleague Ivan.Nash@AdvTalent on 908.378.8980 to discuss the role and/or your application.