JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Biotech
Company Size
Small 100 – 1000
Requested Expertise
Regulatory Affairs / /
Profile Required
Degree in Lifesciences
> 10 years working experience in RA
Leadership experience (managing managers)
Fluent English
Ability to build relationships with other areas of the organisation and influence
Project Description
Interim management for EU biotech (awaiting permanent recruitment).
– Premarket support to product development
– Full product lifecycle management responsibility
– New product introductions
– Global RA strategy across your product portfolio
– Post market regulatory activities
As Director Regulatory Affairs you will:
– Provide guidance on regulatory changes and opportunities to legal teams and executive management
– Establish RA policy and best practices and ensure compliance to them
– Develop regulatory strategies for the maintenance and new product introduction of drugs into these markets
– Acts as the voice of the business in discussions with global regulatory agencies; empowers team members to engage and negotiate confidently
– Your internal partners will be regional and business unit leaders
– Your role will be to foster strong collaborative relationships with these partners in order to achieve business objectives
– Establish best practices for regulatory activities and ensure consistent application across all stages of the product regulatory lifecycle
Therapeutic Area
Immunology,Oncology
Language
English
Hard Skills
Regulatory Dossier
Soft Skills
Management skills
Seniority Level
Experience > 10 years
Starting Date
2024-03-01
Project Duration
6 months
FTE / nb of days per week
4
Project Location
Zug, Switzerland
Remote Flexibility
Yes
Travel Expected
No
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
contact@pharmatch.co