International Associate Regulatory Affairs Director – Lead blockbuster rollouts in ROW? NJ, NYC, PA (Code USA 301020)

Reference: MG301020

Expiry Date: 31-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
New York County
United States

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Job Description

International Associate Regulatory Affairs Director – Lead blockbuster rollouts in ROW? NJ, NYC, PA

My client is an Oncology giant in terms of R&D investment and focus, and have a portfolio of brands in new lifecycle and first registration requiring waived filings in the international and emerging markets. We are seeking 2 hires for this team, as part of their expansion of this workstream!

Note on Covid, Location & Relocation

During Covid, you can stay in place, be hired from and work from home. After the dust settles and probably by Summer 2021, this role will be based in NJ / greater NYC with an option to work from home upto 50% of the time. If your situation requires a relocation, then my client offers a significant package of support for individuals and families both buying or renting housing including costs and allowances for managing costs (the package will mean your move is cost neutral).

Our Client: Well-established, but agile, known for their innovation, and being a highly successful top 5 R&D-based organization with very successful products across oncology, immunology and internal medicines. This company is now expanding their Regulatory team and for Regulatory Affairs Associate Directors for the ROW / Emerging Markets areas. The roles will work closely with the GRLs in the core development groups as well as with the affiliates and for some regions, cluster leads.

About the Role

In this role you will be working on a variety of international MAA and Supplemental NDA projects, developing regulatory strategies and filing plans with the regions and affiliates, lead the ROW sub team for CTD conversions, extra legal documentation, local filing management, responses management as well as for some EMs, preparation / filing of local INDs or Scientific Advice meetings. You will provide strategic input and then lead for your assigned programs regulatory strategy, as well as translating strategic decisions into local plans, following up and leading filing excellent and execution:- 

  • It is essential to have at least 4 to 7 years of Regulatory Affairs experience with post and pre approval submissions in international markets in one of the following: MENA, LATAM or A-P.
  • Able to demonstrate examples of strategic thinking and tactical delivery for registrations in the international markets and be keen on following a ROW career in regulatory.
  • Either experience in Oncology or Internal Medicines ROW Regulatory.
  • You are a good communicator, able to lead teams as well as work with Global demonstrating leadership and regulatory project management expertise, able to coordinate communications and workstreams across the functions.

Benefits and Location

This is a permanent opportunity that can be based (post Covid-19) in one of 2 locations in NJ/PA borders or greater NYC. Until then you can be hired and work from home until at least summer 2021. The company offers a Cadillac relocation package.

The role comes with a competitive salary package and includes a good bonus, quick vesting share plan and an extensive company benefits package, including great health insurance. The company offer summer Friday half days as well as a Xmas shutdown (the latter is non contractual).

Note: My client is willing to buyout stock and bonus for the right candidate. 

Who are we?

ADV Talent is a recruitment agency hiring for major bio/pharmaceutical companies and healthcare organizations mainly in the field of Regulatory Affairs and Regulatory CMC. We want individuals to be self-actualized for their own hiring process. This brings out the individuals to embrace change and identify with their next career move as an opportunity to grow. By this, our applicants grow, and so do our clients.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov or Matt Greig on 855.505.1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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