Local Regulatory Affairs Manager (Area US) - Mendrisio site (Ticino)
Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.
To strengthen our Scientific Affairs Department team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Local Regulatory Affairs Manager (Area US).
Position Summary
Reporting directly to Corporate Functions, the Local Regulatory Affairs Manager is accountable for strategy development, planning and execution of Regulatory Affairs priorities for both new and in-line products in the US market, in line with the FDA regulations.
Key responsibilities
- Definition and execution of US regulatory strategies, providing strategic oversight and, if required, hands-on support for NDAs (mainly 505(b)(2)), ANDAs, INDs, iPSP and formal interactions with the FDA.
- Oversight of early- and late-stage development programs including regulatory due diligence for licensing-in opportunities with critical assessment of regulatory pathways, risks, timelines and probability of success.
- Support the main Area Project Manager in the submission of Life Cycle Management supplements, annual reports and PADERs advertisements/promotional materials, based upon information prepared or provided by Sintetica SA.
- Provide a regulatory strategy and guidance for implementation of CMC/labeling changes impacting US registrations (annual reports, CBE, and PAS classification according to the legislation in force for the US).
- Maintain the post-approval change submission plans together with the main Area Project Manager by ensuring these plans can be executed on time.
- Remain constantly updated on US pharmaceutical legislation and share knowledge with the RA Team members to promote their growth.
Qualifications and skills
- Bachelor's degree in a scientific discipline (e.g., Pharmacist, Pharmaceutical Science, or related discipline); advanced degree preferred.
- At least 10 years of previous experience in regulatory affairs with a focus on the US projects (NDA, ANDA, iPSP, formal meeting, etc.).
- Excellent knowledge of regulatory requirements to support both the development and the life cycle of generic and new drugs in the US context.
- Excellent command of written and spoken English.
- Proven ability to prioritize and multitask with minimal supervision based on interactions with project team members.
- Strong organizational skills and a high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
Preference will be given to candidates based in Switzerland.
We offer
Fulltime permanent employment in a young working environment and positive culture.
Sintetica promotes diversity and gender equality.