Regulatory Affairs Manager-OTC
Randstad AB / Juristjobb / Solna
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Regulatory Affairs Manager - OTC
As a consultant at Randstad Life Sciences, we are your employer, but you have your daily workplace at one of our customers. Your consultant manager is always close at hand, both during and between assignments, to help you develop your career in the direction you dream of.
As a consultant with us, you will receive a competitive salary, benefits and collectively agreed terms. We are responsive to your wishes regarding assignments and tasks and with our broad client portfolio in Mälardalen, we will together adapt your continued career according to your competence, experience and ambition.
At Randstad Life Sciences, we have an offer that means you have the opportunity to develop your skills and/or take extra leave after you have been with us for a while. You will be part of a larger consulting team within Life Sciences and have the opportunity to broaden your network and gain valuable experience from different workplaces.
Right now we have a shorter assignment of 6 months starting immediately, with our customer in Solna.
Possibility of hybrid workplace 60%.
About the assignment:
The business is focused on over the counter medicines (OTC) and consumer products. The products have wide distribution and a strong base in pharmacies as well as in the grocery market.
Responsibilities
Main responsibility will be to work with OTC medicines but may also involve working with Cosmetics, as appropriate and based on experience.
• Support regulatory activities for National and/or European procedures for medicinal products (Decentralised, Mutual Recognition) as appropriate.
• Support regulatory activities for identified Nordic Products and work with Local market Regulatory Colleagues in Norway, Finland and Denmark to ensure work activities are completed in line with the business plan.
• Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met, for instance prepare, review and compile regulatory submissions and responses to the Health Authorities, work with Product Information (artworks, leaflets and SmPCs).
• Develop and support regulatory strategies (local and regional) in line with business plan.
• Continuously update local/global databases, records, trackers and make sure alignment with compliance processes.
• Input to medical, marketing, supply, complaints and pharmacovigilance activities for products on the Swedish and/or Nordics market.
• Responsible for the communication with the local Health Authority and being key contact person for designated products. Ensure regulatory status of on-going activities is communicated appropriately.
• Support regulatory activities for any Cosmetic products as appropriate.
Qualifications
• Experience in Regulatory Affairs working directly with MPA within the pharmaceutical/ Consumer Healthcare industry (required).
• OTC Regulatory Affairs experience and desirable to have a working knowledge of Cosmetic Regulatory Affairs (preferred).
• Proficient in Swedish and English language (required).
About the company
Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential. With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world's most valued working life partner. By combining our passion for people with the power of today's technology, we support people and organizations in realizing their true potential. We call it Human Forward.
Ersättning Not specified
Så ansöker du Sista dag att ansöka är 2024-03-24
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Kontakt Julia Grendler
julia.grendler@randstad.se +46704036701 Jobbnummer 8549006
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