Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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