Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 24 MM++
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Perform regulatory Due Diligence for defined product dossiers and establish gap analysis against country submission content plan for countries in scope
- Develop and implement appropriate regulatory strategies to ensure successful products submission & approval
- Act as counterpart towards regulatory contact from the external partner and ensure productive and efficient interactions
- Define regulatory work package for defined products and coordinate planning of submissions
- Manage applications for new marketing authorization, answer to questions & any other local request, variations and renewals
- Adapt dossiers according to company standards and country specific requirements
- Coordinate the provision of supporting documents with external partner, with regulatory functions and other departments in case of content related issues
- Review regulatory dossiers and documents (protocols, reports and other types of regulatory documentation) liaising with other regulatory functions as appropriate
- Maintain direct contact with local country RAs and external partner and monitor the submission process
- Provide customer and business oriented solutions for problems during submissions
- Ensure understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly
Your qualifications
- Degree in a Life Science or related discipline
- Experience with LCM activities in at least two regions (e.g. Europe, LATAM, APAC)
- Experience in pharmaceutical industry
- Prior experience in performing regulatory due diligence
- English skills (business fluent)
- German skills (business fluent)
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager