REGULATORY AFFAIRS SPECIALIST/COORDINATOR
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REGULATORY AFFAIRS SPECIALIST/COORDINATOR
Fertin Pharma has a solid background in the Nicotine Replacement Therapy (NRT) category, primarily developing and manufacturing pharmaceutical nicotine gum. The pharmaceutical culture is integrated in our daily work.
Fertin Pharma was recently acquired by Philip Morris International (PMI). Together we have one of the most exciting and ambitious strategies set out. We create products to support healthier living.
- Our strategy is to build a smoke-free future by developing and manufacture nicotine-containing products.
- We develop and manufacture high quality self-care wellness products.
- We operate with customers for both European, North American and international markets in addition to progressing development opportunities by ourselves.
With this diverse strategy the regulatory department has a key function to ensure compliance with applicable regulation including e.g. pharmaceuticals, cannabinoids, natural health products, dietary supplements, novel food, cosmetics and food. Together with the global market strategy, it provides a complex landscape of regulatory requirements.
Main Responsibilities:
Your main responsibilities will depend on your experience and interests, but you can expect the job to encompass all types of activities related to regulatory aspects of non-pharmaceutical product life-cycle management activities. You will:
- manage information to be used for labelling of products e.g. lists of ingredients and statements e.g. vegan free, sugar free etc. in cooperation with our suppliers and customers. Prepare ADI calculations.
- deliver regulatory support to Fertin´s product development and business development teams
- maintain internal documentation packages and dossiers submitted to authorities for our non-pharmaceutical products
- maintain licenses and permissions to executed operations within Fertin
- dependent on your qualification and interest you will have the opportunity to support our Regulatory Surveillance team.
Qualifications:
- You have experience working with regulatory guidelines, ISO standards and GMPs from a position in regulatory affairs within the in food and/or nutraceutical and/or pharmaceutical industry. You may also have a background from an authority or agency
- Relevant education within pharmaceutical or food science or technology or related areas is preferred
- As a person you are motivated by keeping things on track, complete tasks and ensure high compliance levels. You are systematic and detail oriented
- You have good communication skills and you are fluent in English
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Vejle.
Jobbet er oprettet på vores service den 14.2.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Vejle
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