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Senior Regulatory Affairs Manager, UK

About Us:

G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.

As demand for our services and solutions continues to increase, we have an exciting new opening for a Senior Regulatory Affairs Manager within our UK team.

This is an outside IR35 role and fully remote.

 

Candidate Requirements: 

  • 5 years (minimum) of generalist regulatory experience, in small and/or large molecule products, consumer healthcare, and/or animal health products.
  • Experience in European procedures, emerging markets and international regions.
  • Previous experience working on CMC and/or other reg docs e.g. annual reports, MATs for Small Molecules & Biosimilars.
  • A natural aptitude for project management, working to deadlines and dealing with a large volume of different country-specific requirements.
  • Experience in paper and electronic regulatory submissions, including delivery to regulatory agencies.
  • Ability to liaise with internal colleagues and client stakeholders to ensure that submission requirements and timelines are met.
  • Small and large molecule experience, ideally across multiple therapy areas and dosage forms.
  • The ability to liaise with internal colleagues and client stakeholders to ensure submission requirements and timelines are mutually understood and in line with standards and deadlines for dossier delivery to regional markets.
  • Excellent communication skills are essential, as are diplomacy and negotiation skills.

For further details, please send your CV to: talent@gandlscientific.com

 

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse.

All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity

  • Contract Type:

    Outside IR35

  • Location:

    Remote

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