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Regulatory Affairs Director

2 months ago

Reading, Reading, United Kingdom Actalent Full time
Job Overview

As a key member of the Actalent team, the Regulatory Affairs Manager will play a critical role in ensuring the company's compliance with UK regulatory processes and national drug legislation.

The successful candidate will provide expert regulatory guidance to the organization, manage regulatory activities for the UK and Ireland, and serve as the Local Person for Pharmacovigilance (LPPV) and the National Pharmacovigilance Contact Person.

Key Responsibilities:

  • Provide UK regulatory expertise to the organization, ensuring compliance with relevant laws and regulations.
  • Manage regulatory activities for the UK and Ireland, including submissions and communications with regulatory authorities.
  • Serve as the LPPV/National Pharmacovigilance Contact Person, ensuring the company's pharmacovigilance activities are in compliance with regulatory requirements.
  • Develop and maintain relationships with regulatory authorities, staying up-to-date on regulatory requirements and changes.
  • Support the launch of innovative drugs, ensuring regulatory compliance and facilitating successful product launches.
  • Collaborate with cross-functional teams to ensure regulatory considerations are integrated into product development and commercialization strategies.

Requirements:

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