Local Regulatory Affairs Manager (Area US) - Mendrisio site (Ticino) — Sintetica SA
- Location
- Mendrisio
- Contract
- other
- Posted
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Role overview
Local Regulatory Affairs Manager (Area US) Mendrisio site (Ticino) Sintetica SA, Mendrisio (TI)
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.
- Local Regulatory Affairs Manager (Area US) Mendrisio site (Ticino) Sintetica SA, Mendrisio (TI)
- We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them.
- 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.
- 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.
- 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.
Main responsibilities
- 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.
Key requirements
- 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.
- What we offer - Fulltime permanent employment in a young working environment and positive culture. - Sintetica promotes diversity and gender equality.
What the company offers
- 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.
Additional details
- Local Regulatory Affairs Manager (Area US) Mendrisio site (Ticino) Sintetica SA, Mendrisio (TI)
- 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.
Notes and original content
- Local Regulatory Affairs Manager (Area US)
- Mendrisio site (Ticino)
- Sintetica SA, Mendrisio (TI)
Questions about this listing
What salary does Sintetica SA offer for this role?
Sintetica SA lists CHF 101'500 - 169'000 gross per year for this position in Mendrisio. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Sintetica SA offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Sintetica SA during the application process, since these details can vary by role even within the same contract category.
Do I need the G permit to apply for this role in Ticino as an Italian cross-border worker?
Yes, if you are resident in Italy within the 20 km border zone. The Swiss employer files the G-permit application at the Ticino cantonal migration office after the contract is signed — first issuance takes 2-6 weeks, then automatic yearly renewal for as long as the employment continues. Weekly return to your Italian home is required to keep the status.
How do I apply for this position at Sintetica SA?
Use the "Apply now" button on this page — it links directly to Sintetica SA's original listing at app.ncoreplat.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
