Regulatory Affairs Expert
4 weeks ago
PharmaRelations is a leading talent services provider for the life science industry in the Nordic region. We specialize in partnering with top organizations in the sector, offering consultancy services, outsourcing solutions, and recruitment of specialists and leaders.
We are seeking a Senior Regulatory Affairs Consultant to join our team in Solna, Sweden. As a consultant, you will have the opportunity to work with various clients and tasks, including global headquarters and local affiliates within pharmaceuticals and medical devices.
Key Responsibilities:- Develop and maintain regulatory strategies for clients
- Prepare and coordinate documentation for regulatory submissions
- Manage client contacts with authorities, including the FDA, EMA, and the Swedish Medical Products Agency
- Act as an affiliate point of contact at headquarters
- Be responsible for a product portfolio
- Represent Regulatory Affairs in project teams and external meetings
- Ensure compliance with regulatory requirements
- University degree in Life Sciences, preferably M.Sc. in Pharmacy or similar
- At least 10 years of experience in the pharmaceutical industry, mainly within Regulatory Affairs
- Broad experience and interest in regulatory procedures within the EU is essential
- Additional experience in quality assurance and/or pharmacovigilance is a merit
- Experience in regulatory procedures outside the EU is a bonus
- Excellent verbal and writing skills in English and Swedish
As a Senior Regulatory Affairs Consultant at PharmaRelations, you will be part of a team of highly skilled and passionate experts across the Nordics. You will have the opportunity to develop and contribute your skills and engagement in various contexts over time. We offer a dynamic and innovative work environment, with opportunities for professional growth and development.
We are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification or age. Religion, political views, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
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