Regulatory Affairs Associate
Regulatory Affairs Associate
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Are you passionate about patient-centric regulatory expertise and possess a high level of creativity and strategic vision Join AbbVie as a temporary Regulatory Affairs Associate in Sweden where you will provide regulatory vision and leadership to the Affiliate. As a key member of our team you will contribute to AbbVies growth by managing regulatory activities and achieving efficient new registrations and variations while maintaining existing marketing authorizations. AbbVie is a global pharmaceutical company with a significant footprint in Scandinavia thereof high future possibilities for further job opportunities.
Key Responsibilities:
Lead regulatory activities in Sweden/Scandinavia in collaboration with the Head of Regulatory Affairs.
Manage new product registrations variations and maintain compliance of marketing authorizations.
Collaborate with Scandinavian/affiliate brand teams local regulatory authorities and other stakeholders to advocate for regulatory strategies objectives and timelines.
If applicable oversee the review and approval of promotional material ensuring compliance with local regulations and internal policies.
Engage with regulatory policymakers and professional associations to stay informed about trends and changes in national and EU legislation.
Ensure compliance within the regulatory department and collaborate with pharmacovigilance and other stakeholders.
Serve as a liaison with European Regulatory Affairs and Corporate groups on regulatory matters.
Support internal audits and inspections in Sweden.
Communicate parallel import/distribution activities to relevant stakeholders within AbbVie.
Support Good Distribution Practice (GDP) activities and provide effective resolution of regulatory issues.
Qualifications :
Degree in Science preferred.
Experience from working in a regulatory and/or similar environment preferred.
Fluent in English and Swedish.
Exceptional communication skills both verbal and written.
Ability to adapt in a dynamic environment and manage priorities effectively.
Collaborative and consultative interpersonal style.
Strong business acumen and computer literacy.
Highly developed project management skills.
Excellent negotiation influencing and presentation skills.
Strong visionary strategic and motivational skills.
If you are ready to contribute to AbbVies vision and ensure the best outcomes for patients and the organization apply now and become part of our Regulatory Affairs team!
Additional Information :
Interested candidates should submit their resume and a cover letter detailing their qualifications and experience.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
