1 Regulatory activity:

·         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.

·         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.

·         Work closely with global regulatory and global experts to understand details, ensure timelines and to provide guidance on Swiss strategy and specifics.

·         Ensure high quality, completeness and timeliness of applications and coordinate with HA/affiliate/HQ to obtain fast approval with best possible label.

Internal stakeholder

·         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.

·         Work closely with global regulatory and key experts to understand details and to lead them on Swiss strategy, timelines and specifics

·         Communicate timely and clearly on key regulatory activities across local and global teams including management

External stakeholder

·         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

2 Deputy Head Regulatory Affairs

·         Act as deputy for the Head of Regulatory Affairs in his absence

·         Interact with local management for discussion and endorsement on filing strategies

·         Full responsibility for dedicated projects and people management tasks

3 Compliance and document management:

·         Work according to internal and external guidances, SOPs and respective timelines

·         document management and archiving of regulatory relevant documentation (ShareNet, BEAMS) and track activities in GRIT and respective trackers

·         Establish and maintain knowledge of SOPs and work instructions

4 Continuous Education:

·         Participate in workshops and events with HAs and on regulatory topics

·         Develop up-to-date regulatory expertise through continuous education

·         Experience sharing with the local regulatory team

Any other job duties that may be assigned from time to time.

• Master’s degree / Ph.D in a relevant scientific discipline e.g. Pharmacy, Biochemistry, Microbiology or related Pharmaceutical Science is required.
• 4+ years of professional experience in the Pharmaceutical Industry / Track record in the field of Swiss Regulatory Affairs, regional or global regulatory experience a plus.
• Experience in managing complex projects, managing cross-functional teams, navigating in a matrix structure, performing under pressure.
• Open and innovative mindset
• Fluent in German, English, good knowledge of French, Italian knowledge a plus
• Skilled in project management and managing complex projects.
• Out of the box thinking while focusing on details.
• Broad experience in regulatory affairs, in innovative regulatory approaches and in getting complex new drugs approved
• Good knowledge of Swissmedic

We are looking for someone to develop and pursue innovative filing strategies with local brand team and global project teams for new filings, lead and ensure high quality applications and fast approvals with best possible label outcome of allocated product portfolio. Deputise for Head Regulatory Affairs,coach new/junior team members and ensure compliance with Biogen SOPs (PSURs, RMPs, CDS updates), databases (e.g. BRIM) and documentation management (BEAMS)