Regulatory Affairs Manager

Clinigen Group; United Kingdom; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A global pharmaceutical services business is seeking a detail-oriented Regulatory Affairs Manager. This role focuses on the regulatory strategy, submissions, and compliance across various regions, particularly in the MENA area. The ideal candidate should hold a Bachelor's in Life Sciences and have substantial experience in regulatory submissions. Key responsibilities include developing regulatory strategies and liaising with product teams and regulatory authorities. Attractive perks include a discretionary bonus scheme and pension contributions.

Benefits

Discretionary Bonus Scheme

Pension contributions 4.5% matched

Life assurance 4 x annual salary

Flexible Benefits Platform

Annual salary review

Enhanced Employee Assistance Programme

Shopping discounts with retailers

Long service awards

Recognition scheme & employee of the year awards

Qualifications

• Strong experience in international regulatory environments, particularly in MENA.
• Experience within the pharmaceutical industry is required.
• Outstanding written, verbal, and interpersonal communication skills.

Responsibilities

• Develop regulatory strategies for product registration in international markets.
• Oversee compliance with product labelling and promotional material.
• Act as primary contact with regulatory agencies in various countries.

Skills

Regulatory submissions management

Organizational skills

Project management

Interpersonal communications

Education

Bachelor's Degree in Life Sciences

Job description

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)
• 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.

Key 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
• 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
• 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.