Regulatory Affairs Manager
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations 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 currently searching for a Regulatory Affairs Manager Consultant to join our team in Copenhagen. The position is home based and office based andis fulltime.
Key responsibilities include:
Major Accountabilities:
Key Performance Indicators:
Education & Qualifications:
MSc in Pharmacy or similar education e.g. university degree in medical/biological science
Experience:
Preferred 2-5 years of experience within Regulatory Affairs from pharmaceutical industry or Health Authorities
Why?
At PharmaRelations we offer a great place to work. You will get the chance to develop your skills, and to work with a team of highly intelligent, innovative and passionate experts across the Nordics. PharmaRelations offer a place where there is room for you to excel, be valued and make a difference. Not just to us, but ultimately indirectly to the patients’ lives we help improve and save every day by servicing the Pharmaceutical industry.
How
For further information do reach out to Head of Medical Interim Denmark Louise Brinking on +45 53769570or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
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.
We are currently searching for a Regulatory Affairs Manager Consultant to join our team in Copenhagen. The position is home based and office based andis fulltime.
Key responsibilities include:
- In accordance with CPO strategy, provide Regulatory Affairs know-how and support to:
- Planned and ongoing submissions and approvals of Marketing Authorizations for EU and national products/projects.
- Timely submission and approval of highest quality labelling for EU and national products/projects.
- Support fast access to the market to optimize growth of market share, sales and product results, both short and long term in defined therapeutic areas. The long-term perspective includes regulatory maintenance of the products with valid Marketing Authorization in Denmark and Iceland.
- Represent our client in facilitation, communication, and negotiation with Health Authorities.
Major Accountabilities:
- High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions.
- Maintain established products according to global and local regulatory plans.
- Translate and handling of Product Information (SmPC, PL, Labelling) within given timelines.
- Update and maintain regulatory databases according to timelines in relevant SOPs.
- Timely submission of Risk Management Plans and educational material.
- Handle Health Authorities requests according to relevant SOPs.
- Initiate, review and second independent approver of artwork.
- Build and keep a highly professional relationship with the Health Authorities and thereby ensure a good atmosphere in the working relationship.
- Support and interact with global regulatory affairs, local market access, local medical- and marketing functions, QA and logistics in accordance with CPO strategies to best support local and global interest for development projects and marketed products and ensure adequate communication with relevant stakeholders.
- Participate in assigned RA sub-teams.
- Contribute in Pharma Compliance Clearance Committee (review of marketing materials) in accordance with current SOP for assigned products.
Key Performance Indicators:
- Timely and high quality submission and approvals of Marketing Authorizations, variations and Health
- Authority requests.
- Timely update of regulatory databases.
- Timely information about Marketing Authorizations and changes in the MAs to relevant stakeholders.
- Quality of relationship with authorities and customers.
Education & Qualifications:
MSc in Pharmacy or similar education e.g. university degree in medical/biological science
Experience:
Preferred 2-5 years of experience within Regulatory Affairs from pharmaceutical industry or Health Authorities
Why?
At PharmaRelations we offer a great place to work. You will get the chance to develop your skills, and to work with a team of highly intelligent, innovative and passionate experts across the Nordics. PharmaRelations offer a place where there is room for you to excel, be valued and make a difference. Not just to us, but ultimately indirectly to the patients’ lives we help improve and save every day by servicing the Pharmaceutical industry.
How
For further information do reach out to Head of Medical Interim Denmark Louise Brinking on +45 53769570or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
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.
Information og data
Denne ledige stilling har jobtypen "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 21.1.2022, 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.
- Jurist
- Kongens Lyngby
- Fredag den 25. februar 2022
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