Regulatory Affairs Manager (International Markets)

Job description

OverviewClinigen 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)

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 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.

Qualifications

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

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

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Extra information

Status

Closed

Education Level

Secondary School

Location

Weybridge

Type of Contract

Full-time jobs

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English