Regulatory Affairs Manager (International Markets)

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

To support our growth, we are seeking a dynamic, detail orientated and collaborative Regulatory Affairs Manager. In this role, you will be responsible for leading and coordinating regulatory strategy, submissions and compliance activities across multiple regions. You will ensure that products meet the regulatory requirements and maintains compliance throughout the product lifecycle. You will act as a key liaison between internal teams, regulatory authorities and external partners.

This is a dedicated Regulatory Affairs Manager role supporting Colonis, a Clinigen Group company. You will sit within the wider Regulatory Affairs team and will work very closely with the Regulatory Affairs Director for Colonis.

You will also collaborate closely with Colonis commercial teams, working hand-in-hand as commercial agreements are established with partners and alongside Supply Chain and Quality functions. The role involves broad interaction across the Colonis organisation, attendance at regular cross-functional meetings and ongoing reporting on regulatory activities.

Key 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, Central Europe and Eastern European markets)
• 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.

While the role is not primarily client-facing, you will engage directly with regulatory authorities, including participation in agency meetings. The role requires someone with hands-on experience managing regulatory submissions in MENA, LATAM, Central Europe and Eastern European markets independently, without relying solely on partner support.

You will be comfortable working with incomplete or evolving information, have submitted in these regions' multiple times, and understand regulatory expectations well enough to anticipate agency questions, reducing reactive firefighting and improving submission efficiency.

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 markets such as LATAM, MENA, Central Europe and Eastern European markets.
• 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

Interested? we would love to hear from you, please apply today for immediate consideration.