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(Sr) Associate Regulatory Affairs
View: 202
Update day: 20-03-2024
Category: Legal / Contracts
Industry: Biotechnology Pharmaceuticals Research
Position: Associate
Job type: Full-time
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Job content
Job DescriptionFour our offices in Baar we´re recruiting for a
(Sr) Associate, Regulatory Affairs – 18 moths fixed term contract
About This Role
In this exciting role you will develop and pursue innovative filing strategies with local brand team and global project teams for new filings. You will lead and ensure high quality applications and fast approvals with best possible label outcome of allocated product portfolio. Another important part is to ensure compliance with Biogen SOPs (PSURs, RMPs, CDS updates), databases (e.g. BRIM) and documentation management (BEAMS)
What You’ll Do
- Develop and pursue innovative and tailored filing strategies for upcoming filings (new products, line extensions)
- Liaise with local brand team/management and global project teams and seek agreement and endorsement of regulatory strategies.
- Lead global expert team through application process, ensure competitive timelines and high-quality documentation. Provide guidance on Swiss strategy and specifics and coordinate with HA/affiliate/HQ to obtain fast approval with best possible label.
- Plan, track and coordinate regulatory activities of the allocated product portfolio, incl. CDS updates, PSUR and RMP submissions according to internal and external guidance, submission of post approval commitments (PACs) and CMC variations.
- Drive regulatory topics in the Brand Team and ensure close collaboration and interaction, keep Brand Team up to date on key regulatory milestones / activities, bring commercially impacting topics to the Brand Team’s attention.
- Keep close interactions with Swissmedic on ongoing topics and maintain a good relationship with the respective case managers at Swissmedic. Seek formal/informal advice on innovative approaches
- Work according to internal and external guidances, SOPs and respective timelines. Establish and maintain knowledge of SOPs and work instructions
- Document management and archiving of regulatory relevant documentation (ShareNet, BEAMS) and track activities in GRIT and respective trackers
- Participate in workshops and events with HAs and on regulatory topics, develop up-to-date regulatory expertise through continuous education
You are passionate about to contribute to innovative regulatory filing strategies and you want to start building your career in Regulatory Affairs. You are open, eager to learn and have the right can-do mindset to solve any challenge with a positive mindset.
Qualifications
Required Skills
- Master’s degree / Ph.D in a relevant scientific discipline e.g. Pharmacy, Biochemistry, Microbiology or related Pharmaceutical Science is required.
- Experience in managing complex projects, managing cross-functional teams, navigating in a matrix structure, performing under pressure.
- Fluent in German, English, good knowledge of French, Italian knowledge a plus
- Professional experience in the Pharmaceutical Industry / tTrack record in the field of Swiss Regulatory Affairs, regional or global regulatory experience a plus.
- Italian language knowledge a plus
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
Additional Information
In this exciting role you will develop and pursue innovative filing strategies with local brand team and global project teams for new filings. You will lead and ensure high quality applications and fast approvals with best possible label outcome of allocated product portfolio. Another important part is to ensure compliance with Biogen SOPs (PSURs, RMPs, CDS updates), databases (e.g. BRIM) and documentation management (BEAMS)
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Deadline: 04-05-2024
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