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16170en
- Contract
- English
- Director
- Legal, Regulatory & Compliance
- Zug
- Healthcare & Life Sciences
Skills
Regulatory affairs, global, pharmaceutical, biotechnology
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This vacancy has now expired
On behalf of our client, an international biotechnology company, Swisslinx is looking for a Global Regulatory Lead in Biosimilars. If this is you, you will develop and execute global regulatory strategies for product development, approval, and life-cycle management, ensuring compliance across major territories (US, EU, JP, China). This role involves leading regulatory activities for biosimilar assets, representing the company with regulatory authorities, managing outsourcing, and providing cross-functional regulatory support.
Contract type - Contract
Start Date - As soon as possible
Location - Baar
Workload - 100%
Duration - 12 months (extension possible)
Your mission:
- Direct global regulatory strategies for projects, programs, and life cycle management.
- Lead global pre-clinical and clinical regulatory strategies.
- Develop and execute the Global Regulatory Plan (GRP).
- Advise on CTA submission strategy and late-stage clinical development plan.
- Set strategic direction for global regulatory submissions, including marketing applications.
- Identify and mitigate regulatory risks; provide regulatory guidance throughout research and development.
- Develop and maintain Core Data Sheets; lead global labeling meetings.
- Collaborate with Regulatory CMC on filing content and risk mitigation; assess impact of CMC changes on licenses or clinical trial applications.
- Organize and prepare clear and effective regulatory submissions; build and maintain relationships with regulatory agencies, contractors, and partners.
- Mentor and guide team members and direct reports; monitor regulatory agency activities and assess their impact.
- Prepare and deliver effective presentations internally and externally; participate in and contribute to relevant external conferences.
- Provide leadership on project teams and input to Regulatory Senior Management; foster global view and improve interdepartmental communications.
Your background:
- 8 years in pharmaceutical/biotechnology industry with technical management experience; minimum 6 years in Regulatory Affairs (Strategy).
- Experience with regulatory aspects of products in pre-clinical and clinical development.
- Late-stage development regulatory experience, including leading significant submissions (e.g., NDA, BLA, MAA); regional regulatory lead experience in US and/or EU preferred.
- Direct experience interfacing with regulatory authorities (e.g., FDA, EMA, PMDA).
- Experience with European regulatory pathways for Biosimilars and filing Biosimilars preferred.
- Good knowledge and interpretation of regulations, guidelines, and policy statements.
- Preparation experience of major regulatory submissions and supportive amendments/supplements.
- Ability to foster positive interactions with regulatory agencies and corporate partners.
- Leadership and influence on project teams and committees to achieve goals.
- Excellent leadership, communication, and organizational skills; ability to prioritize workload.
- Strong interpersonal skills for interactions with senior medical, scientific, and manufacturing staff.
- Sensitivity to multicultural/multinational environments; experience leading multidisciplinary teams.
- Supervisory/mentoring experience, including guiding, training, and prioritizing workload of direct reports (as applicable).
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:
- Direct global regulatory strategies for projects, programs, and life cycle management.
- Lead global pre-clinical and clinical regulatory strategies.
- Develop and execute the Global Regulatory Plan (GRP).
- Advise on CTA submission strategy and late-stage clinical development plan.
- Set strategic direction for global regulatory submissions, including marketing applications.
- Identify and mitigate regulatory risks; provide regulatory guidance throughout research and development.
- Develop and maintain Core Data Sheets; lead global labeling meetings.
- Collaborate with Regulatory CMC on filing content and risk mitigation; assess impact of CMC changes on licenses or clinical trial applications.
- Organize and prepare clear and effective regulatory submissions; build and maintain relationships with regulatory agencies, contractors, and partners.
- Mentor and guide team members and direct reports; monitor regulatory agency activities and assess their impact.
- Prepare and deliver effective presentations internally and externally; participate in and contribute to relevant external conferences.
- Provide leadership on project teams and input to Regulatory Senior Management; foster global view and improve interdepartmental communications.
Your background:
- 8 years in pharmaceutical/biotechnology industry with technical management experience; minimum 6 years in Regulatory Affairs (Strategy).
- Experience with regulatory aspects of products in pre-clinical and clinical development.
- Late-stage development regulatory experience, including leading significant submissions (e.g., NDA, BLA, MAA); regional regulatory lead experience in US and/or EU preferred.
- Direct experience interfacing with regulatory authorities (e.g., FDA, EMA, PMDA).
- Experience with European regulatory pathways for Biosimilars and filing Biosimilars preferred.
- Good knowledge and interpretation of regulations, guidelines, and policy statements.
- Preparation experience of major regulatory submissions and supportive amendments/supplements.
- Ability to foster positive interactions with regulatory agencies and corporate partners.
- Leadership and influence on project teams and committees to achieve goals.
- Excellent leadership, communication, and organizational skills; ability to prioritize workload.
- Strong interpersonal skills for interactions with senior medical, scientific, and manufacturing staff.
- Sensitivity to multicultural/multinational environments; experience leading multidisciplinary teams.
- Supervisory/mentoring experience, including guiding, training, and prioritizing workload of direct reports (as applicable).
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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