Principal Regulatory Affairs Officer

Select Pharma Recruitment; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

A recruitment agency in pharmaceuticals is seeking a professional for a mid-senior level role focusing on regulatory input for product submissions. You will manage complex regulatory submissions, ensure compliance with UK and EU regulations, and provide support throughout the product lifecycle. The ideal candidate should have a degree in a scientific field and substantial experience in regulatory affairs. This full-time position offers the opportunity to work independently while contributing to important projects in pharmaceutical manufacturing.

Qualifications

• Substantial regulatory experience across the full product lifecycle.
• Solid understanding of pharmaceutical manufacturing processes.
• In-depth knowledge of UK and European regulatory affairs legislation.

Responsibilities

• Provide full regulatory input and support for assigned products.
• Ensure timely regulatory submissions and communicate delays.
• Review quality documentation for regulatory compliance.

Skills

Regulatory experience

Report writing

CMC regulatory experience

Analytical methods understanding

Negotiation skills

Communication skills

Planning and organization

Education

Degree in a scientific discipline

Job description

Select Pharma Recruitment provided pay range

This range is provided by Select Pharma Recruitment. 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 Recruitment

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 due diligence and report writing; ability to write up a report with the information found (deficiencies, errors etc in the dossier or territory specific updates needed prior to submission)
• 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