Regulatory Affairs Director

2 weeks ago

London, Greater London, United Kingdom Actalent Full time

Regulatory Affairs Manager Position

We are Actalent, a dynamic and innovative pharmaceutical company dedicated to bringing groundbreaking therapies to markets. As a key member of our team, you will play a crucial role in ensuring the compliance and success of our regulatory activities in the UK and Ireland.

Key Responsibilities:

  • Provide expert regulatory guidance to our organization, ensuring seamless compliance with UK regulatory processes and national drug legislation.
  • Manage all regulatory activities across the UK and Ireland, maintaining up-to-date knowledge of regulatory requirements.
  • Serve as the Local Person for Pharmacovigilance (LPPV) and the National Pharmacovigilance Contact Person, ensuring the highest standards of pharmacovigilance.
  • Support the launch of innovative drugs, collaborating with cross-functional teams to ensure regulatory readiness.
  • Liaise with regulatory authorities, fostering strong relationships and ensuring timely submissions.

Qualifications:

  • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful regulatory submissions and product launches.
  • Expert knowledge of UK regulatory processes and national drug legislation, with a strong understanding of regulatory requirements.
  • Strong communication and organizational skills, with the ability to work in a fast-paced environment and manage multiple priorities.

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