Regulatory Affairs Manager (m/w/d)
Regulatory Affairs Manager
Location : Baar
Duration : 02 / 09 / 2024 to 01 / 09 / 2025
Key Responsibilities :
- Responsible for leading regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialization.
- Responsible for collaboration and relationship management with the strategic partner(s) and vendors for assigned products.
- Responsible for regulatory documents, submissions, and compliance issues. Influences stakeholders to ensure deliverables are in line with technical standards, quality, and timelines.
- Drives innovative process change for improved efficiency across regulatory processes and requirements.
- Monitors and provides notification of changes in requirements as well as assessing the impact of agency guidance updates relevant to technical aspects of submissions.
- Provides training to project teams on requirements and expectations on regulatory systems and processes for GxP document management.
- Represent the company with regulatory authorities, contractors, and corporate partners.
- Provide regulatory support for various departments, projects, and teams / committees.
Key responsibilities :
- BS degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject
- 6 to 8+ years pharmaceutical / biotechnology industry with 4 to 6+ years regulatory experience
- SME in regulatory processes
- Good knowledge of applicable regulations, and submission standards / requirements.
- Ability to interpret regulations and guidelines.
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
- Strong communication and project management abilities in global and virtual teams
- Strong interpersonal skills and the ability to collaborate effectively across project teams
- Ability to work independently with minimal supervision
- Competent in the use of electronic document management tools.
- Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks.
If this role is of interest to you, or anyone from your network, feel free to send me your CV and expected hourly rate for immediate consideration.
I am specialised recruiter taking care of various projects within the Life Sciences Industry.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
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