Manager, Regulatory Affairs

Jobgether; Deutschland; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobgether, on behalf of a partner company, seeks a Manager, Regulatory Affairs based in Germany to lead regulatory submissions across EMEA, Asia Pacific and Latin America, ensure timely, compliant execution, and provide strategic guidance.

You will coordinate with sponsors, project teams, clinicians and business development, mentor juniors, review IMPDs and IBs, and contribute to proposals and feasibility studies.

Qualifikationen

• Bachelor's or equivalent with major in medical/biological/health discipline.
• Alternative two-year qualification with at least eight years of clinical research/regulatory experience.
• 5–7+ years in pharma/CRO with senior regulatory affairs exposure.

Aufgaben

• Lead regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America.
• Ensure submissions are accurate, tracked, and compliant with timelines.
• Provide regulatory guidance throughout projects and advise on country-specific requirements.
• Review IMPDs, IBs, and study documents for alignment with ICH GCP and local rules.
• Communicate submission status and regulatory considerations to sponsors and teams.
• Support BD activities by reviewing budgets, contributing to proposals and feasibility reports.

Kenntnisse

Regulatory leadership

Cross-functional collaboration

Regulatory submissions

Strategic thinking

Stakeholder management

Ausbildung

Bachelor's degree in medical/biological/health sciences

Alternative qualification + 8+ years CRO/pharma experience

Jobbeschreibung

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Regulatory Affairs based in Germany.

This role offers the opportunity to lead regulatory affairs activities across multiple international markets within a dynamic clinical research environment. You will oversee regulatory and ethics committee submissions, ensuring accurate, timely, and compliant execution throughout the study lifecycle. The position combines strategic regulatory guidance with hands‑on project coordination and stakeholder management. You will work closely with sponsors, project teams, medical and scientific experts, and business development colleagues. The role also provides opportunities to contribute to proposals, feasibility assessments, contract discussions, and technical documentation. As a senior member of the team, you will share your expertise through coaching and mentoring junior colleagues. Your work will directly support the development and regulatory advancement of innovative medical products and clinical research programs.

Accountabilities

• Lead and coordinate regulatory and ethics committee submissions and maintain required approvals across EMEA, Asia Pacific, and Latin America.
• Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained in accordance with applicable requirements and timelines.
• Provide expert regulatory guidance throughout clinical research projects and advise stakeholders on country‑specific and international regulatory requirements.
• Review and provide recommendations on technical and study documentation, including IMPDs, IBs, and other relevant materials, to ensure alignment with ICH GCP and applicable country requirements.
• Communicate submission status, timelines, risks, and regulatory considerations effectively with sponsors, Project Managers, CRAs, and Medical & Scientific Affairs teams.
• Support business development activities by reviewing study budgets and costing, contributing to contract negotiations, preparing regulatory sections of proposals and feasibility reports, and participating in bid defense meetings.
• Contribute to broader regulatory project activities and provide strategic input to support study and business objectives.
• Train, coach, and mentor junior regulatory affairs professionals and, where required, provide direct line management.

Requirements:

• Bachelor's degree or equivalent four‑year college education with a major concentration in medical, biological, physical, health, pharmacy, or another relevant scientific discipline.
• Alternatively, a two‑year college qualification or equivalent education/training, such as a nursing or life sciences degree, combined with at least eight years of clinical research experience, including areas such as Clinical Research Associate or Regulatory Affairs roles.
• Minimum 5–7 years of experience within the pharmaceutical or CRO industry, with demonstrated senior‑level regulatory affairs or clinical start‑up experience.
• Proven leadership, organizational management, planning, strategic thinking, scheduling, monitoring, and critical evaluation skills.
• Strong understanding of regulatory processes and clinical research requirements, with the ability to interpret and apply ICH GCP and country‑specific regulations.
• Excellent written and verbal English communication skills, with the ability to present complex information clearly and concisely.
• Strong interpersonal and relationship‑building skills, including confidence supporting business development activities and face‑to‑face client meetings.
• Demonstrated ability to collaborate effectively across cultures and geographies.
• Ability to manage multiple priorities, meet deadlines, and remain effective in a fast‑paced and continuously changing environment.

Benefits:

• Opportunity to work in an international clinical research and regulatory affairs environment.
• Exposure to regulatory activities across EMEA, Asia Pacific, and Latin America.
• Opportunities for professional development, coaching, and leadership growth.
• Collaborative and supportive working environment focused on innovation and high‑quality clinical research.
• Opportunity to contribute to programs supporting the development of innovative medical products.
• Inclusive workplace culture that values diverse backgrounds, perspectives, collaboration, and creativity.
• Additional compensation, healthcare, flexibility, and other employment benefits may be provided according to the local employment package and applicable company policies.