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16209en
- Contract
- English
- Mid-Senior level
- Legal, Regulatory & Compliance
- Zug
- Healthcare & Life Sciences
Skills
regulatory affairs, management, stakeholder management, contract management, regulations, european geography, submissions
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This vacancy has now expired
On behalf of our client, an international biotechnology company, Swisslinx is looking for a Regulatory Affairs Senior Manager in Biosimilars. If this is you, you will lead regulatory affairs for assigned projects, manage relationships with strategic partners, oversee regulatory submissions and compliance, drive process improvements, and represent the company with regulatory authorities and partners.
Contract type - Contract
Start Date - As soon as possible
Location - Baar
Workload - 100%
Duration - 12 months (extension possible)
Your mission:
- 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 commercialisation.
- Responsible for collaboration and relationship management with Biogen’s 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.
Your background:
- 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, Biogen’s innovator business and with vendors.
- 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.
What's on offer
- An initially 12-month contract, with possibility of extension.
- Opportunity to direct global regulatory strategy at an internationally known biotechnology company.
- A competitive salary.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
Contract type - Contract
Start Date - As soon as possible
Location - Baar
Workload - 100%
Duration - 12 months (extension possible)
Your mission:
- 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 commercialisation.
- Responsible for collaboration and relationship management with Biogen’s 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.
Your background:
- 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, Biogen’s innovator business and with vendors.
- 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.
What's on offer
- An initially 12-month contract, with possibility of extension.
- Opportunity to direct global regulatory strategy at an internationally known biotechnology company.
- A competitive salary.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
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