Senior Manager & Associate Director Regulatory Affairs >> Lead Early, Mid-Late Development phase programs and grow into a Director for a Global Biotech

Reference: JPC594

Expiry Date: 30-09-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Cumberland County
United States

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Job Description

Have you worked on early development programs?
Have you led the strategic input for line extensions or NDAs?
Do you have experience in the preparation if INDs, Brochure and Briefing documents, Pre-IND, EOP2 meetings, Paediatric or Orphan studies?

Then you might be the candidate our client is looking for!

We are helping a reputable Global Biotechnology company in the RTP area with their search for passionate and innovative Senior Managers and Associate Directors.
Our client is renowned for providing employees with real opportunities for growth and career development, whether that means that you work on honing your strategy skills or move to management in the near future.

Due to the accelerated growth of the company’s pipeline in new therapy areas, our client is looking for a skilled professional to lead early development or mid-and-late development programs, before that person is moved into a Global role as a Director.
Both roles come with a great package and include a strong basic salary, an excellent bonus (approx. 20%), and LTIs for AD grade, as well as a generous benefits package and a very flexible working model, with the opportunity to work fully remote.

Key responsibilities:

- Developing and implementing the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the GRL
- Serving as the primary regional point of contact for the GRL, affiliates, and other Practices/Functions
- Being the primary point of contact for the health authorities (FDA, EMA), to build strong relationships with them
- Ensuring that the regional regulatory strategies, risks and mitigations and overall plans are effectively discussed with, endorsed by and communicated to the GRL and other functions and affiliates as needed
- Coordinating the regional submission team
- Delivering regulatory documents and submissions in line with the applicable regulations, directives, and guidelines, in line with internal strategies and timelines.

You would be a good fit for this role if:

- You have drug development regulatory experiences in ideally early and/or late development with direct experience of supporting NMEs using an adaptive pathway or have additional experience with rare disease’ submissions or Orphan Drug Designation, BTD or similar
- You have experience building effective partnerships - identifying opportunities and taking actions to build effective relationships within the team and with other areas.
- You are well versed with influencing skills - with thought through rationale and effective communication skills, able to influence key decisions.

To Apply!

Please contact me at / 587.216.9302 or my colleague Ivan.Nash@AdvTalent / 908.378.8980 to discuss the role and/or your application.