Principal Regulatory Affairs Officer

Select Pharma Limited; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A prominent pharmaceutical company in the United Kingdom seeks a Regulatory Affairs Specialist to provide full regulatory support for products. The ideal candidate will have significant experience across the product lifecycle, particularly with CMC regulatory submissions. Responsibilities include managing submission timelines and ensuring compliance with UK and EU regulations. This full-time role requires strong communication and organizational skills.

Qualifications

• Degree in a suitable scientific discipline (biological/chemistry/life sciences).
• Substantial regulatory experience across the full product lifecycle.
• Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
• Solid understanding of pharmaceutical manufacturing processes.
• Broad experience managing regulatory submissions.
• In-depth knowledge of UK and European regulatory affairs legislation.

Responsibilities

• Provide regulatory input and support across the submission phase.
• Ensure regulatory submissions are timely and communicate delays effectively.
• Review quality documentation for regulatory compliance.
• Provide regulatory input on artworks for product launches.

Skills

Regulatory experience

Strong CMC knowledge

Planning and organisation

Effective communication

Negotiation skills

Education

Degree in biological sciences

Job description

Overview

This range is provided by Select Pharma Limited. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from Select Pharma Limited

Responsibilities

• Responsible for the provision of full regulatory input and support for assigned products across the submission and assessment phase which includes the preparation, submission and response to questions for new Marketing Authorisation Applications. Manages increasingly complex submissions making decisions independently and with minimal referral to line manager.
• Ensure regulatory submissions are made on time and any delays are communicated to all relevant stakeholders in a timely manner so as to minimize impact to the business
• Provide regulatory input on pharmaceutical development and CMC and review quality documentation to ensure regulatory compliance with UK and EU legislation
• Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.

Qualifications and Required Experience

• Degree in a suitable scientific discipline (biological/chemistry/life sciences).
• Substantial regulatory experience across the full product lifecycle.
• Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
• Solid understanding of pharmaceutical manufacturing processes, analytical methods and regulatory expectations for CMC compliance.
• Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
• In depth knowledge of UK and European regulatory affairs legislation and guidance.
• Planning and organisation skills - Ability to handle multiple tasks/projects and manage priorities accordingly.
• Able to work under pressure and to strict deadlines.
• A confident credible communicator with good negotiation skills.
• Able to build relationships at all levels of the business.
• Excellent written communication skills with attention to detail.
• Able to independently identify and initiate tasks/projects.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing

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