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Senior Regulatory Affairs Officer (NPD)

Bio Products Laboratory (BPL) has a new opportunity for an experienced Senior Regulatory Affairs Officer (NPD) to obtain new and maintain existing Marketing Authorisations whilst managing all regulatory activities related to one or more new drug applications and maintaining drug licences for designated products in a designated territory.

With a wealth of experience and knowledge around Reg Affairs and NPD, the incumbent will propose and participate in Regulatory strategy decision making for new Marketing Authorisations in a designated territory and obtain the necessary and sufficient documentation for applications to relevant authorities and manage the regulatory submission process to approval, through product launch and beyond.

Key duties & responsibilities –

  • Make proposals for product licensing strategies for new products and new markets.
  • Independently manage the regulatory aspects and licensing of Orphan Drugs within the US, EU and/or Intercontinental countries.
  • Provide strategic and operational input to obtain new Marketing Authorisations in the US, European Union (EU) or Intercontinental markets for designated products and manage the product life cycle.
  • Independently, maintain existing licences (commitments, variations, renewals).
  • Independently plan for, communicate directly with the relevant BPL departments to obtain and or generate appropriate documentation necessary to satisfy health authority requirements in the relevant countries.
  • Independently make source documentation available and supervise the generation of regulatory dossiers in eCTD format.
  • Prepare and submit any type of application (Clinical Trial Application, Marketing Authorization Application, variation application, Orphan Drug application, renewal application)
  • Communicate directly with the MHRA (country of origin) and other health authorities seeking advice, guidance or clarification of legal issues or submission processes. Active participation on meetings with FDA and EMA together with superior.
  • Actively maintain RA data bases (RIM/ IDMP), documentation and procedures to ensure regulatory compliance of BPL products released to market.
  • Continuously identify and make proposals for minor and major improvements related to work place, processes and/or systems

Experience & qualifications to make you successful in the role –

  • First degree in Life Sciences and/or MSc Reg Affairs degree from TOPRA
  • Records of attendance at relevant Regulatory Affairs conferences and training.
  • Pharmaceutical experience, Biologics being a plus.
  • A wealth of experience in a Regulatory Affairs function involved with world-wide licencing activities.
  • Basic knowledge of ICH and solid knowledge of all aspects of an ICH CTD structured dossier.
  • Solid experience with EU requirements (CEN, DCP, MRP, National) from drug development to final approval and product launch support.
  • Solid experience of managing and executing post approval changes in EU and US. Experience with the Intercontinental Region is a plus.
  • Experience of managing requests from FDA, EMA, national competent authorities and full understanding of the regional procedural time lines.
  • Experience in obtaining and maintaining manufacturing and clinical trial authorisations in the US, EU and Intercontinental region.

In return we offer –

  • Competitive salary, and benefits to include a performance related bonus
  • 25 days holiday
  • Pension
  • Private Health Insurance
  • Life Insurance
  • On-site free parking, with a subsidised restaurant

Headquartered in Hertfordshire, Bio Products Laboratory (BPL) invest in the latest research, technology and manufacturing methods and are continuously supplying high quality plasma-derived products worldwide.

We are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.  Since privatising from the NHS in 2013, BPL has gone through huge change and growth as we aspire to be the leader in our field.  BPL is based in Borehamwood, in a secure campus surrounded by natural beauty, lakes and wildlife.

Please apply today for immediate consideration.

 

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