Regulatory Affairs Project Manager

ZipRecruiter; Cambridge; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Project Manager to lead compliance for labelling and artwork. The role requires a degree in Life Sciences and experience in the pharmaceutical industry, particularly with MHRA and FDA regulations. Candidates can expect a hybrid working model, attending the office three days a week in Cambridge.

Qualifications

• Degree in Life Sciences required.
• Pharmaceutical industry experience is essential.
• Experience with Regulatory Affairs, Artwork, and/or Labelling.

Responsibilities

• Lead labelling & artwork activities for compliance.
• Review & approve labelling documents and packaging.
• Lead ANDA/NDA submissions and FDA filings.

Skills

Regulatory Affairs experience

Knowledge of MHRA and FDA regulations

Experience in pharmaceutical industry

Education

Degree in Life Sciences

Job description

Job Description

Allerton Bishop is supporting a leading pharmaceutical company in the search for a Regulatory Affairs Project Manager. Our client is a specialty pharmaceutical company operating on a global basis.

The Role:

• Lead labelling & artwork activities, ensuring local and international compliance.
• Review & approve labelling documents, artwork & packaging for new launches and portfolio updates.
• Lead ANDA/NDA submissions, FDA promotional material filings & core data sheet development.
• As the Regulatory Affairs Project Manager, you will partner with cross-functional teams to deliver compliant, high-quality packaging and artwork.

Your Profile:

• Degree in Life Sciences.
• Pharmaceutical industry experience is essential.
• Regulatory Affairs, Artwork and/or Labelling work experience.
• Knowledge of MHRA and FDA regulations is essential.

Our client is offering a hybrid working pattern. Their offices are in Cambridgeshire and the successful applicant will need to attend the office 3 days per week.

Regulatory Affairs Project Manager | Senior Regulatory Affairs Specialist | Regulatory Affairs Manager | Senior Regulatory Affairs Officer | Pharmaceutical | Labelling | Artwork