More Details
Freelance Consultant Local Regulatory Manager (m/w/d) (EN)
[13193]
Regulatory Affairs
Job title: Freelance Consultant Local Regulatory Manager (m/w/d) Industry: Pharma Skills: Regulatory Affairs Start of project: 01.10.2023 Duration of the project : 12 Months Location: Basel, Schweiz We are seeking a motivated Regulatory Affairs Specialist to join our client's team and support their growth. Key Responsibilities: ·Prepare and execute global regulatory strategies in collaboration with the regulatory affairs team. ·Provide regulatory expertise and guidance to project teams, supporting product development and life-cycle management. ·Interact with national/regional regulatory agencies, participating in meetings and preparing submission packages. ·Prepare, review, and consolidate relevant technical information for regulatory dossier submission. ·Offer regulatory expertise for the EMEA and Swiss (Swiss Medic) region, advising on specific requirements and supporting regional activities. ·Monitor global and EMEA health authority regulations to ensure compliance and proactively address regulatory challenges. Education and experience : ·Minimum Bachelor in life sciences, Master are welcome ·3+ years of regulatory affairs experience in Pharmaceutical industry ·Experience in EU and Swiss regulatory affairs is a must, and in global regulatory affairs is a plus ·Experience in overall drug development processes and strategies a must, in biologics is a plus Personal qualities: ·Excellent Strategic skills ·Good English written and verbal communication skills - French or German a plus ·Ability and willingness to work collaboratively with global team members across multiple time zones (US, APAC, EMEA) ·Ability to prioritize competing timelines / projects ·Analytical and problem-solving skills
Skills: Regulatory Affairs
We are seeking a motivated Regulatory Affairs Specialist to join our client's team and support their growth.
Key Responsibilities:
- Prepare and execute global regulatory strategies in collaboration with the regulatory affairs team.
- Provide regulatory expertise and guidance to project teams, supporting product development and life-cycle management.
- Interact with national/regional regulatory agencies, participating in meetings and preparing submission packages.
- Prepare, review, and consolidate relevant technical information for regulatory dossier submission.
- Offer regulatory expertise for the EMEA and Swiss (Swiss Medic) region, advising on specific requirements and supporting regional activities.
- Monitor global and EMEA health authority regulations to ensure compliance and proactively address regulatory challenges.
Education and experience :
- Minimum Bachelor in life sciences, Master are welcome
- 3+ years of regulatory affairs experience in Pharmaceutical industry
- Experience in EU and Swiss regulatory affairs is a must, and in global regulatory affairs is a plus
- Experience in overall drug development processes and strategies a must, in biologics is a plus
Personal qualities:
- Excellent Strategic skills
- Good English written and verbal communication skills - French or German a plus
- Ability and willingness to work collaboratively with global team members across multiple time zones (US, APAC, EMEA)
- Ability to prioritize competing timelines / projects
- Analytical and problem-solving skills
Bella Iglesias