REGULATORY AFFAIRS SPECIALIST
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Vejle
REGULATORY AFFAIRS SPECIALIST
You will be successful in this position if you master the regulatory role. You may have experience within one or more of the regulatory regimes where Fertin operates. The most important is that you are motivated by understanding legislation and guidelines and manage to bring this into action in an innovative and fast-moving environment.
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.
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:
- provide regulatory support to customers and other departments in Fertin regarding regulatory matters and queries.
- prepares documentation for product applications and notifications, variations and other regulatory life-cycle management activities.
- communicates internally and externally with authorities, customers, suppliers and consultants
- participates in projects and working groups as a representative of the Regulatory Affairs function, including new product development projects and optimization projects.
- 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 consultancy or an authority or agency.
- Relevant education within pharmaceutical or food science or technology or related areas is preferred
- You are 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 30.5.2022, 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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