Regulatory Affairs Director

2 weeks ago

London, Greater London, United Kingdom Pharmiweb Full time
Job Description

Job Title: Head of Regulatory Affairs

Company: Pharmiweb

Location: UK

Job Type: Full-time

Industry: Pharmaceutical

Job Description:

Regulatory Strategy Development:

  • Develop and implement regulatory strategies to expedite the approval process for investigational products.
  • Provide expert guidance on regulatory requirements and compliance to support clients in navigating complex regulatory landscapes including ICH GCP, Medical Device including AI and ML algorithms.

Leadership and Team Management:

  • Lead and inspire a team of regulatory affairs professionals, fostering a culture of excellence and continuous improvement.
  • Provide mentorship and guidance to team members, promoting their professional development.

Client Engagement and Business Development:

  • Build and maintain strong relationships with clients, understanding their unique needs and providing tailored regulatory solutions.
  • Drive business development initiatives to expand our client base and contribute to the organic growth of our client.

Merger and Acquisition Support:

  • Collaborate with cross-functional teams to assess regulatory aspects of potential mergers and acquisitions.
  • Play a key role in due diligence activities and integration efforts to ensure regulatory compliance and a smooth transition.

Commercial Skills:

  • Demonstrate strong commercial awareness, understanding market trends, and identifying opportunities for business expansion.
  • Engage in negotiations with clients, regulatory agencies, and other stakeholders to achieve favorable outcomes.

Qualifications and Experience:

  • Highly experienced in regulatory affairs within the pharmaceutical or healthcare industry.
  • In-depth knowledge of UK and international regulatory requirements and guidelines.
  • Proven track record of successful leadership in a regulatory affairs role, preferably in a consulting capacity.
  • Excellent communication and interpersonal skills with the ability to build and maintain strong client relationships.
  • Strong business acumen and a demonstrated ability to contribute to business development and organizational growth.

Education:

  • Bachelor's, Master's, or Ph.D. degree in a relevant scientific or regulatory field.

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