Regulatory Affairs Director

1 month ago


London, Greater London, United Kingdom GSK Full time
Job Title: Regulatory Affairs Director

At GSK, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs function, you will play a critical role in ensuring the development and execution of regulatory strategies for our assigned assets.

Key Responsibilities:
  • Develop and implement regulatory strategies to support the development program, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams, including global commercial teams and local regulatory teams, to secure the best possible labelling commensurate with available data.
  • Lead regulatory interactions and Health Authority submission/review processes, ensuring effective communication and negotiation with regulatory agencies.
  • Ensure compliance with regulatory requirements at all stages of product life, from development to post-marketing.
  • Advocate persuasively to senior leaders in GSK and with Health Authorities, providing critical regulatory assessment and advice.
Requirements:
  • Bachelor's degree in biological or healthcare science.
  • Several years of experience in Global Regulatory Affairs, with extensive knowledge of relevant therapeutic areas and clinical trial and licensing requirements.
  • Proven track record of leading development, submission, and approval activities, including successful relationships with Health Authorities.
  • Strong business acumen, with the ability to influence decision-making at the highest levels of R&D and with external partners.
Preferred Qualifications:
  • Masters or PhD in a relevant field.
  • Established external network into other pharmaceutical companies and recognized as an expert in regulatory affairs.
  • Proven ability to drive process improvement in a matrix environment and with demonstrated leadership in the application of innovative approaches.


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