Technical Regulatory Affairs Manager - Large Molecule a Basel

pubblicato
contatti
Barbara Sorce, Basilea Professionals Health Care & Life Sciences
tipologia
Altri contratti
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specifiche della posizione

pubblicato
luogo di lavoro
Basel, Basilea-Città
settore
Life Sciences
tipologia
Altri contratti
riferimento
15726
contatti
Barbara Sorce, Basilea Professionals Health Care & Life Sciences
telefono
058 201 55 50

descrizione

For our client, a pharmaceutical company in Basel area we are looking for an

Technical Regulatory Affairs Manager - Large Molecule

  • Start date: May 2021
  • End date: 1 year
  • Work location: Basel
  • Remote/Home Office: at the moment home office

Tasks & Responsibilities:

  • Be accountable for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.
  • Be accountable for submissions of high quality CMC regulatory documents to health authorities in accordance with Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
  • Effectively manage regulatory changes throughout the product life cycle.
  • Represent Pharma Technical Regulatory on cross-functional teams and work effectively with multiple disciplines and personalities.
  • Contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
  • Be accountable to keep abreast of regulatory procedures and changes.
  • Contribute to driving efficiency by assertively simplifying, taking risk and cutting out waste.

Must haves:

  • Min Bachelor, Master or Doctor preferred in Life Science or a law degree with pharma industry (****)
  • Min 5 y in Technical Regulatory Affairs (****)
  • Hands-on experience working on CMC (****)
  • Experience working on large molecules (****)
  • Experience working within post-approval lifecycle and regulatory submissions (****)
  • Possesses the ability to prioritize and work effectively both within a team environment and independently.
  • Ability to influence teams and functions in defining global technical regulatory strategies.
  • Takes ownership, is decisive, and uses a network and creativity to solve problems and progress programs and projects.

Nice to have:

  • Experience working in and agile environment
  • Experience working for a large pharma company