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Regulatory Operations Lead / Associate Director

Switzerland   •  Negotiable  •  Permanent, Full time

Are you a Regulatory Operations expert looking for an interesting career move? Are you wanting to step into a leadership role for the first time, or grow your current leadership responsibilities? This could be the role for you

Cpl life sciences Switzerland are exclusively partnered with an innovative and well-renowned biopharmaceutical company with a global footprint and an extensive, well-balanced product portfolio.

Wanting to bring on board an experienced Regulatory Operations Lead (Associate Director level in the business), our client is interested in speaking with candidates with enough Regulatory experience and leadership credentials to manage their small, but highly impactful and successful team.This individual will play a vital and visible role within the business, and will naturally be seen as the succession plan for the Director, who youll be brought in to deputise on a day-to-day basis.

Due to the relatively young nature of the business, you will have the opportunity to work with a degree of autonomy and will be a valued and respected voice within the function. With potential system upgrades and other internal changes afoot, you will stand as the Key Business Owner for systems that fall under the Regulatory umbrella and constantly be used as a sounding board for new ideas to shape and develop the function. With huge growth plans in the pipeline before 2025, this is an exciting opportunity to begin your leadership journey for the very first time, or build on the leadership experience you already have.

What youll be doing:

  • Providing key eCTD expertise to all relevant internal parties
  • Compiling and submitting eCTD submissions across UK, EU & Switzerland
  • Build on external vendor relationships
  • Act as the Regulatory Operations representative for internal x-functional teams and support users and contributors accordingly
  • Provide insight to optimise global submission standards and publishing best practices, implementing new guidance as required
  • Participate in system audits, inspections and due-diligence activities
  • Act as Business Owner for internal Regulatory systems
  • Deputise the Global Regulatory Operations Group Leader and provide leadership within the team

What youll need:

  • Solid educational background or qualified by CV
  • Leadership experience strongly preferred, but open to people with strong leadership capabilities
  • 8+ years experience in the Regulatory Affairs Operations space with a strong understanding of drug development
  • Minimum of 8 years' experience in pharmaceutical regulatory affairs operations, with a good understanding of drug development.
  • Experience using EDMS & RIMS
  • Hands-on experience working with XEVMPD

To apply, or find out more detail about this role, please email Amaree.Rey@cpl.com or call +41 61 547 03 83.

  • Agency: Cpl Life Sciences
  • Reference: JO-2209-500257
  • Posted: 2nd September 2022
  • Expires: 30th September 2022

Cpl Life Sciences

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