Regulatory Affairs Manager to PolyPeptide

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 a specialized Contract Development & Manufacturing Organization for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. The broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1.

Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India.

The employees at PolyPeptide, take pride in contributing to active pharmaceutical ingredients that make a real difference in people’s lives and health. Thus, you can become part of work that truly matters—every day. The peopleare driven by values of trust, innovation, and excellence. This is reflected in how to collaborate, how to solve problems, and how to take responsibility for quality and safety for the patients who are ultimately affected by PolyPeptide’s work.

PolyPeptide is a fast-growing company. Growth brings high pace, change, and new opportunities for both employees and the business.

If you are looking for a workplace where purpose, community, and development go hand in hand, then PolyPeptide is the right place.

About the position

PolyPeptide is looking for a Regulatory Affairs Manager to the manufacturing site in Malmö. The RA department is responsible for world-wide registrations of the drug substances manufactured by PolyPeptide Sweden. This includes preparing and maintaining the CMC documentation for drug substances for applications for all clinical phases as well as for commercial use. The department interacts with customers and authorities on all continents of the world and with the other PolyPeptide sites in France, Belgium, the US and India.

You will be part of a team of highly skilled professionals within Regulatory Affairs and also work in cross-functional teams with members from other departments such as Development, Quality and Sales. Within the cross-functional team, you will be responsible for ensuring regulatory submission requirements are adhered to and take the lead in responding to regulatory questions from customers and authorities. It is important to be able to follow current regulations and guidelines and at the same time use innovative and constructive thinking for an optimal outcome. You will be encouraged to actively participate in change management activities, working closely with the other functions involved.

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

• Bachelor's degree in chemistry, pharmacy, or similar
• Five years of experience working in the pharma industry in Regulatory Affairs or in another function like Quality, Analytical or Development.
• Experience with CMC.
• Excellent communication skills, both written and verbal, with the ability to interact effectively at all levels of the organization as well as with customers and regulatory authorities.
• Fluent in English and Swedish/Scandinavian, both spoken and written.

Meriting:

• Additional work experience and education within organic chemistry, analytical chemistry, chemical manufacturing, regulatory affairs, pharmacy or similar.
• Proven track record in preparing successful regulatory submissions.
• Experience with peptides or other active pharmaceutical ingredients

Although being part of a team, you must enjoy and be able to work independently and take responsibility for your duties. You are expected to strive for personal development as well as for PolyPeptide’s development and continuous success.