Senior Manager, Drug Regulatory Affairs

Senior Manager, Drug Regulatory Affairs

Santhera Pharmaceuticals

Pratteln, Switzerland

Scope of Work

The Senior Manager, Drug Regulatory Affairs, is responsible for leading a range of global regulatory activities, encompassing both strategic and operational responsibilities across drug development, registration, and postmarketing phases. This role offers the opportunity to work in close collaboration with key cross-functional teams - including Clinical Operations, Clinical Sciences, Pharmacovigilance, Biostatistics, Preclinical and CMC, as well as Marketing and Commercial.

Please note: We are considering both Manager and Senior Manager levels for this position, depending on the candidate’s experience.

Key Responsibilities

• Anticipating, planning and driving post-approval procedures: Preparation of regulatory documents, ensuring quality and accuracy, coordinating cross-functional input, and leading submissions, including variations/extensions, PAMs, renewals, scientific advice and meetings with health authorities, and acting as the main HA regulatory contact point;
• Global expansion of Agamree: Serving as contact point for local partners and representing DRA in operational tasks for new markets; providing regulatory support for filings in RoW countries; managing postapproval activities in collaboration with local partners;
• Regulatory Intelligence: Identifying and monitoring relevant guidance, regulations, and sources to ensure ongoing regulatory compliance;
• Providing cross-functional support as required: Supporting Safety and Pharmacovigilance (PSURs, DSURs, PASS, RMP, etc.), Clinical Science/Operations, Quality Assurance, Supply Chain, and Commercial (review of promotional/non-promotional materials, market launch), and participating in due diligence activities;
• Critical review of documents: Ensuring accuracy, scientific validity, and optimal presentation of key documents such as IBs, protocols, and IMPDs;
• Document management: Filing and archiving regulatory documents per SOPs and maintaining electronic filing systems and internal regulatory archives;
• Clinical Trial Authorisation applications and maintenance: Preparing and submitting clinical trial applications and amendments, managing trial notifications, contributing to clinical trial strategy decisions, supervising regulatory CRO counterparts, liaising with regulatory authorities, supporting the Study Management Team with regulatory guidance, and assisting DS&PV with DSUR preparation and submission.

Required Qualifications & Experience

• A minimum of 5–8 years of experience in Drug Regulatory Affairs in a pharmaceutical company or contract research organization (CRO);
• A minimum of a master’s degree in life sciences;
• Knowledge of CH, EU and international regulations;
• Previous experience in operating within complex matrix organizations;
• Fluency in English, both written and oral;
• Knowledge of German and other languages would be an asset.

Required Competencies & Skills

• Excellent communication, interpersonal and networking skills;
• Self-motivation, personal resilience, perseverance, energy and drive;
• Ability to work independently and collaboratively, as required, in a matrix organization;
• Excellent planning and organizing skills;
• Flexibility in adapting to changing priorities and deadlines;
• Capable of dealing with ambiguity, risk taking and decision making in a fast-paced entrepreneurial environment;
• Open minded, solution oriented.

For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required.