Our client is a well-established, global pharmaceutical company with over a century of history, specializing in high-quality therapies across key areas such as anesthesia, analgesia, and acute care. Headquartered in Southern Switzerland, the company focuses on continuous innovation to improve drug formulation, safety, and patient outcomes worldwide.To support their international expansion, we are seeking an experienced Regulatory Affairs Manager dedicated to leading strategy and compliance for the US Market.Position SummaryReporting directly to Corporate Functions, the Regulatory Affairs Manager (US Market) will be responsible for the strategic development, planning, and operational execution of Regulatory Affairs priorities for both new development programs and in-line products in the United States, in full compliance with US FDA regulations.Key ResponsibilitiesUS Regulatory Strategy & Submissions: Define and execute regulatory strategies for the US market. Provide strategic oversight and hands-on support for NDAs (with a primary focus on 505(b)(2)), ANDAs, INDs, iPSPs, and formal meeting interactions with the US FDA.Development Programs & Due Diligence: Oversee early- and late-stage development initiatives, conducting regulatory due diligence for licensing-in opportunities, including critical assessments of regulatory pathways, risks, timelines, and probability of technical/regulatory success.Life Cycle Management & In-Line Support: Partner with the Area Project Manager to manage post-approval submissions, annual reports, PADERs, and regulatory reviews for advertising/promotional materials.CMC & Labeling Changes: Provide strategic direction and guidance for implementing CMC and labeling changes affecting US registrations (including classification and execution of CBE, CBE-30, and PAS filings under current FDA guidelines).Maintenance & Compliance: Maintain post-approval change submission plans in coordination with project management to ensure timely execution and compliance.Regulatory Intelligence: Stay up-to-date with evolving US pharmaceutical legislation, guidelines, and FDA policies, serving as an internal subject matter expert to mentor and foster growth within the broader RA team.Qualifications and Skills RequiredEducation: Bachelor’s degree in a scientific discipline (Pharmacy, Pharmaceutical Chemistry, Biology, or related field); an advanced degree (Master's, PharmD, or Ph.D.) is preferred.Experience: Minimum of 10 years of progressive experience in Regulatory Affairs, with a strong, hands-on background in US-focused projects (NDA, ANDA, 505(b)(2), IND, iPSP, and formal FDA meetings).US Regulatory Expertise: In-depth knowledge of US FDA regulatory requirements governing both drug development and full post-approval life cycle management for generic and new pharmaceuticals.Languages: Full professional proficiency in written and spoken English is required.Soft Skills & Management:Proven ability to work autonomously, prioritize tasks, and manage complex projects with minimal supervision.Team player with excellent communication skills: Proven ability to collaborate effectively with cross-functional and multi-site teamsExceptional organizational skills and keen attention to detail.Demonstrated track record of coordinating multiple cross-functional initiatives in an international environment. #J-18808-Ljbffr
Regulatory Affairs Manager (US Market) Arbeitgeber: Randstad Switzerland
Unser Kunde, ein globaler Pionier in der Pharmaindustrie mit Sitz in Kaiseraugst, bietet eine dynamische und unterstützende Arbeitsumgebung, die auf Innovation und Zusammenarbeit ausgerichtet ist. Mitarbeiter profitieren von flexiblen Arbeitszeiten, der Möglichkeit, im Home Office zu arbeiten, sowie umfangreichen Weiterbildungs- und Entwicklungsmöglichkeiten, um ihre Karriere voranzutreiben. Die Unternehmenskultur fördert Teamarbeit und kontinuierliches Lernen, was es zu einem hervorragenden Arbeitgeber für Fachkräfte im Bereich klinische Studien macht.
