Associate Director Regulatory CMC ‘Abs (EU focused? Gain direct US experience)

Reference: Oli30042021

Expiry Date: 30-05-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Horgen
Switzerland

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Job Description

Associate Director Regulatory CMC ‘Abs (EU focused? Gain direct US experience)

Location: Thalwil, 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).

This role is assigned to Matt Greig and Oli Dimitrov at ADV Talent Partners group which includes Advanced Search & Selection GmbH (Zug). Please call one of us in the first instance asking for Matt or Oli on +44 207 801 3388 or send a full CV to cv@advtalent.com

The Company

This organization achieves >14 Billion USD per annum with a less than 10000 employees, because they develop ground breaking medicines, and now are expanding their portfolio in a way which CMC regulatory people will find a useful challenge. 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 wantingness to gain more global and possibly US experience.

The roles are open to Managers and Snr Managers, who want to gain their first grading at 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.

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.

To Apply!

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

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380 for UK and 855.505.1382 for USA.

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