Associate Director Global Regulatory CMC mAbs, strong M3, gain US, Zurich Area or Part Remote

Reference: OLI10567SEPT

Expiry Date: 14-11-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

Associate Director Global Regulatory CMC mAbs, strong M3, gain US, Zurich Area or Part Remote

We are recruiting for a Regulatory Affairs Associate Director CMC to join an international biopharmaceutical company and provide support and strategic leadership to teams and submissions in the EU, US and the ROW.

The Company

This organization has achieved a run of successful registrations in the last 10 years and has a T/O of >10 billion USD per annum with a less than 8000 employees, mirrored by the fact they successfully develop ground-breaking medicines, are expanding their portfolio in a way which CMC regulatory people will find a useful as there is always a new NME and Ph 3 drug to work on. The company is well-known and matches other Basel-based success stories for their innovation and ingenuity.

You will work in a new team which is spearheading a new franchise, requiring strong DS on recombinants and mAb’s as well as a desire to gain more global and possibly US experience.

The roles are open to Snr Managers, who want to gain their first grading at an Associate Director, or be in a company which has this, as well as experienced Associate Directors who want to have more US and global responsibility. We have a few roles in this team, signed off this week.

Location: Zurich, Switzerland

Note on Covid: This role post Covid will be based in the greater Zurich area (south), but ‘til then, individuals can work from home. Relocation support is available both to Switzerland and also in Switzerland. The company offer great basic salaries and packages (even by Swiss standards).

Role & Responsibility

  • Accountable for RA CMC strategy and oversight for EU and international RA CMC submissions including responses to HA questions (Ph2B, 3, MAA/BLA/NDA).
  • Ensures that the regional or global CMC strategies are consistent with the teams and business goals, compliant, and meet regulatory requirements.
  • Provides gap analysis and identifies author/expert documents required for QoS/M3 submissions and collaborates with CMC development teams and manufacturing to meet this.
  • Oversight for your assigned projects for CMC submissions and responses to within agreed timelines.
  • Leads X-functional teams responsible for the preparation of submissions and responses.
  • Supports/defends/explains CMC regulatory strategy, any risk mitigation, and for overall filing plans (for CMC RA components) to technical and therapy leadership teams and own sub-teams.
  • Responsible for management, coaching and development of direct reports as applicable.

Compensation & Benefits

Other than you do not have to work in Boston, New Jersey or California, to gain the full global CMC strategy and responsibility in my client’s organization, they offer a high-end Zug/Zurich level type salary, bonus with a decent performance multiplier, and a strong RSU based stock plan with quicker vesting. Normal benefits are on top! The company will buyout annual bonuses and stock for the right persons and will offer a relocation package for the right person relocating from the EU.

To Apply!

To apply for this role, please contact Oli Dimitrov on +44 207 801 3388 or Matt Greig on +44 207 801 3386. Alternatively, please send a full CV to or follow the registration process on the site and we will reply by return.

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