Associate Director CMC Regulatory ** Grow or consolidate your Small Molecule LCM exp? Big brand LCM rollout ** Top Biotech with several Blockbusters ** MA, NC or US Remote

Reference: JPC552

Expiry Date: 30-06-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Norfolk County
United States

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Job Description

About My Client – This well-known Biotech Company

What I like about my client is their fundamental commitment to their therapeutic area, when other Big Pharmas left this therapy area, this company kept going! Now this organization has many products in their therapy area and has treated many of patients in their segment with one of their well-known products. Additionally, the company has grown into other TAs, and will continue to do so. Another item, which I think you will benefit from is, this is a politically “low noise” company, the line manager (who we placed) is a compassionate manager with great engagement and experience in LCM and has a strong track record in managing people up and across.

This organization is a USD 10B plus annual T/O company, but they still have less than 8000 employees, which they achieve in regulatory and regulatory CMC by being efficient, working in matrix, and having some of the best systems and processes in place I have seen in my hiring career. They are agile without being “lean”.

This company is now hiring for an Associate Director of RA CMC for Lifecycle Management, working on a new small molecule which is beginning its worldwide rollout. You will lead / support new market entry, clustered Vars, and major line extensions, as well as working externally with the CMO (DS is inhouse, DP is through CMOs), regulatory vendors (for authoring and distributor markets), and internally with therapy regulatory, manufacturing, QA and supply chain.

About The Role

This is an opportunity for you to work world-wide, applying your existing US CMC RA and international experience (in one major region outside the US), for a brand that is / will be registered in US, Canada, LatAm, Europe, China and Asia Pac. It’s a global role. You will be responsible for co-developing lifecycle strategies, as well as ensuring agency interactions for your assigned brand are planned for, anticipated and supported (through the GRL, Hub or Affiliates RA Teams), as well as identification and mitigation of Risks, planning for timelines etc. The organization has PMs in each team, this is the type of regulatory planning you will want to do to identify opportunities to file early with your therapy regulatory partner.

Package & Location

The organization is based in 2 locations in the USA. One is Boston, MA and the other is in the southern States. You can work either remotely or in one of the 2 sites noted. The company encourage visits to HQ and reimburse you fully for how ever many trips you feel are necessary.

Additionally, you will receive a decent stock plan, annually, as well as a performance bonus, in a company known for its performance multipliers, and their salary ranges are typically seen as upper quartile. The company will consider stock buyouts and other incentives to join.

To Apply

Please contact one of our account team asking for Christian or Javier, on US 908.332.9157 or alternatively, please send a full CV to myself, and I will reply by return.

ADV Talent will help you each step of the way and we know this client and their teams extremely well.