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
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