Regulatory CMC Manager

Employer
Hobson Prior
Location
Switzerland / Iceland, Reykjavík
Salary
£99946.80 - £108275.70 per annum
Closing date
12 Oct 2020

View more

Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Permanent
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Hobson Prior are in search for a Regulatory CMC Manager to join a leading biopharmaceutical organisation dedicated to the development and manufacturing of innovative biosimilar medicines. This is a permanent position to be either located in Zurich or Reykjavik.

Job Responsibilities:

  • You will act as the Regulatory representative in cross-functional biosimilar development teams.
  • Contribute proactively towards preparation of technical sections of dossiers such as IMPD, IND and Module 3/2.3 of MAA, BLA.
  • Close interaction with project management, regulatory operation, manufacturing, quality control and analytical development teams.
  • You will provide active support towards regulatory CMC strategy development.
  • Partaking in Health Authority meetings and preparation of responses to Health Authority questions (US, EU, global).
  • Working with Regulatory Operations for the management of regulatory database.

Key Skills:

  • Excellent organizational and communication skills (both in written and verbal English).
  • Team player.

Requirements:

  • You will have a minimum of 3 - 5 years biopharmaceutical industry experience.
  • Master's degree in science (pharmacy, biology, chemistry) or higher would be preffered.
  • CMC regulatory authoring experience or deep technical expertise and experience writing protocols, reports and technical rationales.
  • Proven experience in cross-functional teams.
  • Some knowledge of EU and US regulatory is an asset.
  • Manufacturing and QA/QC experience is desirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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