Hybrid Regulatory Affairs Manager

Posted 3 weeks ago

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About the role

  • Regulatory Affairs Manager leading regulatory strategy and compliance activities across international pharmaceutical markets. Collaborating with internal teams and external partners for product lifecycle management.

Responsibilities

  • Develop and implement regulatory strategies for product registration and maintenance in international markets. Prepare, review, and submit regulatory documents to health authorities across multiple regions (e.g. LATAM, MENA)
  • Provide responses to regulatory authority queries and ensure timely approvals.
  • Oversee product labelling, packaging, and promotional material compliance with local regulations.
  • Conduct regulatory reviews and provide due diligence report.
  • Identify and mitigate regulatory risks impacting product launches or market continuity.
  • Act as the primary contact with regulatory agencies, distributors, and consultants in international markets.
  • Interact with Quality, Supply Chain, Commercial and Project teams to align regulatory requirements with business objectives.
  • Submit variations, renewals and PSUR’s for existing products.

Requirements

  • Bachelor's Degree (or preferably higher degree) in Life Sciences or scientific discipline
  • Experience within pharmaceutical industry
  • Must have strong experience in international regulatory environments, with particular emphasis on the MENA region, especially Qatar, UAE and Saudi Arabia.
  • South American regulatory experience would also be advantageous (not essential).
  • Proven ability to successfully manage regulatory submissions
  • Strong operational regulatory background required
  • Experience within a service provider environment is desirable but not essential
  • Excellent organisational and project management skills
  • Outstanding written, verbal and interpersonal communications skills
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Benefits

  • 27 days holiday plus bank holidays
  • Discretionary Bonus Scheme
  • Pension contributions 4.5% matched
  • Life assurance 4 x annual salary
  • Flexible Benefits Platform with £25/month Company contribution
  • Annual salary review
  • Independent financial advice service
  • Enhanced Employee Assistance Programme
  • Shopping discounts with retailers
  • Long service awards
  • Recognition scheme & employee of the year awards

Job title

Regulatory Affairs Manager

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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