REGULATORY AFFAIRS SPECIALIST IN NICOTINE CONTAINING PRODUCTS
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REGULATORY AFFAIRS SPECIALIST IN NICOTINE CONTAINING PRODUCTS
Are you ready for a career move where you will have international exposure and a direct impact on the overall result of the company? Fertin Pharma A/S is looking for a dedicated specialist for regulatory team within smoke-free reduced risk products: nicotine containing products (NCP).
Our Business
By joining Fertin, you will embark on what we believe is a purposeful mission – and probably one of the most exciting and ambitious strategies set out building a smoke-free future together with our owner Philip Morris International (PMI). At Fertin Pharma our sole mission is to support healthier living. We help leading global brands create pharmaceutical and nutraceutical products based on a range of oral delivery platforms. With our new owner onboard, Fertin will continue to pursue its mission and at the same time be a key enabler in building a smoke-free future.
“PMI has chosen to do something incredible. We’re totally transforming our business and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide”
About the job – regulatory specialist
The Regulatory Affairs department holds 14 skilled employees in Vejle and 2 colleagues at Fertin India R&D site in Mumbai. The department is covering a diverse range of regulatory frameworks and we are grouped in teams to support knowledgesharing and professional sparring.
Nicotine containing products have gained significant success as a cigarette substitution product. To succeed in the ambitious mission, we are therefore strengthening our regulatory team within the NCP segment.
The regulatory framework around NCP products is complex and rapidly changing for which reason a part of the job is to monitor the regulatory landscape and ensure that new requirements are identified, evaluated and implemented.
The NCP business at Fertin is rapidly growing. The regulatory process around NCP is not yet fully settled. You therefore have a great opportunity to influence the future regulatory process and the content of this position.
Main Responsibilities
- You will be responsible for regulatory aspects of oral products with nicotine focusing on legality and safety of products.
- You will contribute to establishing a robust and effective product notification process and you will ensure that products are notified as applicable in relevant markets
- You will be responsible for compilation of applicable regulatory documentation packages and product notifications.
- You have direct communication with the regulatory counterparts at our customers as well as PMI on regulatory aspects related to product development and product launch.
- You will prepare certificates, product statements etc. requested from our customers
- You take part in new product development project as well as optimization and scale-up projects.
Personal capabilities
As a Regulatory Senior Specialist, you are in the center of the activities. You are aware of your stakeholders and have a good understanding of the full value chain. You like to communicate across the organization and invite the regulatory function into discussions where needed.
You are focusing on the regulatory details – however you have the capability to translate the regulatory requirements into a language that can be understood by colleagues with another background.
You are motivated by teamwork, have a supportive attitude, and contribute to a good team spirit.
You are flexible and adaptive and can adjust rapidly to new, unknown, challenging situations.
Core competencies, knowledge and skills requirements
- You have a master’s degree in food science, food technology, pharmacy, chemistry or a similar technical/academic background You have in depth knowledge within regulatory processes and can integrate it into practice on an operational level.
- You have experience from a position in regulatory affairs, QA or related areas working with interpretation of legislation, guidelines and preparation of regulatory or quality documentation.
- You can have experience within pharmaceutical, food, supplements, medical devices or similar area
- Your fluency in English both in writing and speaking, as well as your excellent communication and negotiation skills will enable you to act in an international working environment.
We offer
- To play a key role in supporting healthier living for people all over the world
- To work with top tier pharma and nutraceutical companies in developing their business
- To be part of a dynamic team and ambitious company, with nice and dedicated employees who are focused on supporting their customers in a professional way
- There is flexibility for hybrid working.
Application Deadline: Friday, January 13, 2023
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 5.12.2022, 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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