AboutPolyPeptide
PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) 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. 

Its 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. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

The PolyPeptide values:

• Trust: We build and maintain trust in all our relationships – both with each other and with our customers. We support each other and work as a team
• Innovation: We are curious and driven by finding smart solutions to the challenges we face.
• Excellence: We always strive to deliver high quality and adapt to meet the needs of our customers

About the position
PolyPeptide is looking for a Regulatory Affairs Representative to the manufacturing site located in Strasbourg (France) or Braine-l’Alleud (Belgium).

• The RA department is responsible for world-wide registrations of the drug substances manufactured by PolyPeptide Belgium and France. This encompasses the preparation and ongoing maintenance of CMC documentation for drug substances, supporting applications across all clinical phases as well as commercial use.
• The department interacts with customers and authorities on all continents of the world and with the other PolyPeptide sites in Sweden, 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, Analytics and Quality.
• Within the cross-functional team, you will be working on regulatory submissions and coordinate responses 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.

• As a point of contact, you will be responsible for ensuring that files are submitted to the relevant authorities (monitoring, reviewing, redacting) and also organizing and planning all regulatory activities for your project. This entails making decisions and consistently providing updates on the progress of your activities
• If necessary, you may be responsible for training colleagues or raising their awareness regarding the regulations.
• 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 Braine-l’Alleud (Belgium).

Your qualifications

Minimum requirements:

• Bachelor's degree in Regulatory Affairs, chemistry, pharmacy, or similar
• Minimum two years of experience working in the pharma industry in Regulatory Affairs or in another function equivalent to Quality, Analytical or Development.

• 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 French, both spoken and written.

Additional attributs:

• Additional work experience and education within organic chemistry, analytical chemistry, chemical manufacturing, regulatory affairs, pharmacy or similar.
• Proven track record in preparing successful quality/regulatory documentation
• Experience with peptides or other active pharmaceutical ingredients
• Experience with Veeva Vault RIM submissions
• While functioning as a collaborative team member, you must also demonstrate the ability to work independently and take full responsibility for your duties. You are expected to actively pursue personal development alongside contributing to PolyPeptide’s ongoing growth and success.

What We Offer:

• A dynamic and stimulating environment, with real opportunities for growth.
• A collaborative and inclusive work environment.