Principal Regulatory Affairs Officer

Select Pharma Limited; United Kingdom; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading pharmaceutical company in the United Kingdom is seeking a Mid-Senior level Regulatory Affairs Specialist to provide regulatory input and support for new Marketing Authorisation Applications. The ideal candidate will have a strong background in regulatory submissions and CMC, with an emphasis on timely communication and compliance with UK and EU legislation. This is a full-time role offering the chance to work in a dynamic environment with multiple tasks and deadlines.

Qualifications

• Substantial regulatory experience across the full product lifecycle.
• Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
• In depth knowledge of UK and European regulatory affairs legislation and guidance.

Responsibilities

• Responsible for full regulatory input and support for assigned products.
• Ensure regulatory submissions are made on time and delays communicated.
• Provide regulatory input on pharmaceutical development and CMC.

Skills

Strong due diligence and report writing

Planning and organisation skills

Excellent written communication skills

Strong negotiation skills

Education

Degree in a suitable scientific discipline

Job description

Select Pharma Limited provided pay range

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

• 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

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