Manager or Senior Manager Regulatory CMC Drug-Device Combinations ** RTP, North Carolina (Code USA 100921-1)

Reference: MG100921

Expiry Date: 10-12-2021

Categories Biotech, Devices, Pharmacy, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Wake County
United States

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Job Description

Manager or Senior Mngr Regulatory CMC Drug-Device Combinations ** RTP, North Carolina

About My Client

My client is a well-known and highly successful biotech with <> 10 high value drugs in market, and a significant size of T/O at approx. $15 Billion (the company generates 2-4 times as much value per employee than the average of the top 10 R&D Bio-tech companies). The organization are known for their science and I mean their ability to translate research and discovery into the successful development of new innovative medicines. They organize across multiple modalities, using successfully shared technology platforms, whether this is in manufacturing, or as it pertains to this role, for shared injectors and smart devices used across more than one drug in more than one treatment.

Note on Covid and location!

My client will consider hybrid working for experienced individuals or possibly remote working. The company will allow some home / office based on your skillset and initial capability. The site in North Carolina is a large campus, with both GMP and QA functioning in the same place. There are other regulatory teams based on-site. Relocation support is considered applicable for the right individual.

About The Role

These 2 new roles report to a line manager we know well, as we helped hire them, and the individual has implemented a ladder for you to ascend, whether you are a manager or a senior manager, you will be coached and mentored to take on more and more challenging projects, based on your starting points and long-term goals for your own career.

You will be working in matrix with therapy regulatory, regulatory CMC and quality, in support of the following:-

  • Execute, guide and shape regulatory strategies for new registration submissions and post-approval applications in core markets and world-wide, working with partners and contract manufacturers (CMOs) as necessary
  • Coordinate and prepare regulatory submissions including responses to questions from health authorities and competent bodies – with one to one support from your manager
  • Monitor and adapt regulatory requirements and ensure compliance within scope of responsibility for assigned regions communicating readily
  • Provide regulatory input at the project team level and with the CMC sub-teams and CMOs
  • Identify regulatory risks and provide risk mitigation as appropriate
  • Co-develop regulatory processes and procedures to support objectives
  • Monitor legislative and regulatory developments in the assigned area and inform pertinent cross-functional team members
  • Take part in industry workgroups and forums for assigned topics.

About Your Background

Required Skills

You will have between 2-5 years in Drug-Device Combination products from either a regulatory or development background (if you authored or co-authored regulatory submissions) or in a similar or more junior role.  A minimum of 2 years’ experience with combination products; experience with drug delivery systems including PFS (pre-filled syringes) or AIs (auto-injectors) preferred.

The Package

You will receive a higher level basic salary and, depending upon grade, a bonus with both personal and company multipliers, and for the senior manager a stock plan.

The company will fund based on the individual some support for relocation if necessary, as well as provide funding for travelling into the office 2-3 times per quarter if you are remote.

To Apply!

If you wish to apply for this role, please contact me, Matt Greig on 908-332-9157 for more information, or send a full CV to Alternatively, please press the red “Apply for position” button and follow the registration process.

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