Senior Regulatory Affairs Consultant

PharmaRelations

Sweden - Stockholm

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PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialize in partnering with some of the top and most innovative organizations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are a Nordic organization with over 270 colleagues and with offices in Sweden, Norway, Denmark and Finland. Our headquarter is located in Solna, Sweden. We provide expert services that span from clinical to post-marketing phases.
We are therefore strengthening our team of Regulatory consultants with a permanent position, a Senior Regulatory Consultant within our interim services based in our office in Solna, Sweden.

Tasks and responsibilities
As a consultant within our interim services you will have the opportunity over time to work with various clients and tasks. It could be global headquarters and local affiliates mainly within pharmaceuticals and medical devices.

• Regulatory strategy development and maintenance
• Preparing and coordinating documentation for regulatory submissions
• Being responsible for the clients contacts with authorities (FDA, EMA, the Swedish Medical Products Agency, etc.)
• Affiliate point of contact at headquarter
• Responsibility for a product portfolio
• Regulatory representative in project teams
• Representing Regulatory Affairs in external meetings
• Compliance

Qualifications

• University degree in Life Sciences, preferably M.Sc. in Pharmacy or similar
• Around 10 years of experience in pharmaceutical industry mainly within Regulatory Affairs
• A broad experience and interest in regulatory procedures within EU is essential
• Additional experience in quality assurance and/or pharmacovigilance is a merit
• Experience in regulatory procedures outside EU is a bonus
• Very good verbal and writing skills in English and Swedish

Who are we looking for
We believe you are curious to apply your skills and experience in new situations. You are eager to learn new things and find out how you can contribute in different situations. It could be brain-teasing regulatory challenges or sharing skills/experience with colleagues at PharmaRelations, developing our services, spreading our mission or taking on a task related to our team-building activities.

Why PharmaRelations?
At PharmaRelations we are pround to be a certified Great Place to Work. You will be part of a team of highly skilled, innovative and passionate experts across the Nordics. With us, you can develop and contribute with your skills and engagement in various contexts over time. You could make a difference not only in one specific pharmaceutical company but on different assignments to support the development and maintenance of pharmaceuticals and medical device in the Swedish Life Science for the patients.

What is the next step?
Welcome to submit you application. We will contact candidates selected for interview as applications come in. Due to GDPR, we cannot receive any CVs via e-mail. For more information, contact Shiva Hobbi Nowzari, +46701652264 / [email protected]

At PharmaRelations 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.