Regulatory Affairs Manager – Peptide Drug Substances

DEDENROTH; Malmö kommun; On-site; SEK 750,000 - 1,100,000; Full time

Job summary

PolyPeptide is seeking a Regulatory Affairs Manager for its Malmö manufacturing site. The RA department handles worldwide registrations of drug substances and maintains CMC documentation for clinical and commercial use. You will collaborate with Development, Quality and Sales, and interact with authorities globally.

You report to the Head of Regulatory Affairs in Sweden. The position is based at our Malmö office and is a full-time role.

Qualifications

• Bachelor's degree in chemistry, pharmacy, or similar.
• Five years of pharma industry experience in Regulatory Affairs or related functions.
• Experience with CMC (Chemistry, Manufacturing, and Controls).
• Excellent written and verbal communication, with interactions at all organization levels and with customers/regulatory authorities.
• Fluent in English and Swedish (spoken and written).

Responsibilities

• Be part of Regulatory Affairs and cross-functional teams (Development, Quality, Sales).
• Lead regulatory submission activities and respond to regulatory questions from customers and authorities.
• Ensure compliance with current regulations and contribute to change management activities.

Skills

Regulatory affairs

CMC

Communication skills

English language

Swedish language

Education

Bachelor's degree in chemistry, pharmacy, or similar

Job description

PolyPeptide is seeking a Regulatory Affairs Manager for its Malmö manufacturing site. The RA department handles worldwide registrations of drug substances and maintains CMC documentation for clinical and commercial use. You will collaborate with Development, Quality and Sales, and interact with authorities globally.

You report to the Head of Regulatory Affairs in Sweden. The position is based at our Malmö office and is a full-time role.