Manager, Regulatory and Pharmacovigilance

TN Spain; Madrid; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in Madrid seeks a Manager for Regulatory and Pharmacovigilance. You will lead projects, manage local contacts, and provide strategic regulatory input. The role emphasizes career development in a diverse, inclusive environment focused on rare diseases and oncology.

Formación

• Strong experience within the pharmaceutical or CRO industry.
• Proven success in managing global projects.
• Proficiency in English (written and verbal).

Responsabilidades

• Assume leadership for regulatory tasks and project management.
• Provide regulatory strategic input and expert advice to clients.
• Ensure training compliance and foster professional relationships.

Conocimientos

Project Management

Communication

Problem Solving

Interpersonal Skills

Attention to Detail

Educación

University degree in Biomedical sciences

Natural sciences

Health Sciences

Herramientas

MS Office

Descripción del empleo

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Manager, Regulatory and Pharmacovigilance, Madrid

Location: Madrid, Spain

Job Category: Other

EU work permit required: Yes

Job Description

The Manager, Regulatory and PV (Network) will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities.

The Manager will also act as Local Contact Person for the designated country.

Job Responsibilities

1. Assume leadership and functional representation for projects and/or deliverables of medium/high complexity, ensuring effective coordination, management, and execution of regulatory tasks, driving the team to meet targets and comply with procedures.
2. Develop strategy and manage setup activities (Project Management Plan, joint operating procedures, core documents), ensuring compliance with department standards. Support team members in preparing project strategy.
3. Act as Local Contact Person for the designated country.
4. Provide regulatory strategic input to internal and external customers, promptly identify and address risks, and implement preventive measures. Solve problems and resolve performance issues or delivery failures.
5. Provide expert advice to clients, addressing complex queries and changes in local regulations or guidance.
6. Set up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned projects.
7. Ensure correct training assignment to and training compliance by the LCPs.
8. Prepare client invoices and review/approve vendor invoices.
9. Provide training, coaching, and mentoring to junior staff members.
10. Foster professional relationships with internal and external contacts at local and international levels to ensure smooth service delivery.
11. Prepare and contribute to the Regulatory Newsletter and update the regulatory database with new information.
12. Ensure collection, QC review, and timely dissemination of regulatory intelligence related to departmental deliverables. Support legislation interpretation and impact analysis.
13. Support client qualification activities, ensure audit readiness, and participate in audits/inspections, providing responses to findings.
14. Contribute to vendor qualification assessments, ensure training and compliance, and evaluate existing vendors.
15. Assist in securing new business by participating in BDMs, developing and reviewing regulatory proposals, and managing regulatory budgets.
16. Drive departmental and company initiatives, act as a change champion, and manage implementation plans.

Qualifications

• University degree in Biomedical sciences, Natural sciences, or Health Sciences (e.g., Nursing, Pharmacy, or a scientific discipline); or equivalent experience or relevant PV background.
• Strong experience within the pharmaceutical or CRO industry or regulatory bodies, with demonstrated project management skills.
• Proven success in managing global projects.
• Excellent organizational, management, planning, strategizing, monitoring, scheduling, problem-solving, and critique skills.
• Exceptional written and verbal communication skills.
• Outstanding interpersonal skills in a fast-paced, deadline-driven, and evolving environment.
• Meticulous attention to detail.
• Ability to manage multiple tasks, prioritize, and adapt to changing work demands.
• Sound judgment and independent decision-making ability.
• Proficiency in English (written and verbal).
• Proficiency in MS Office applications (Word, Excel, PowerPoint).

Additional Information

We offer excellent opportunities for career development in projects related to rare diseases, oncology, and neurology. Our workplace emphasizes diversity, inclusion, and a human-centric environment where all backgrounds are valued.

Our core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships. We look forward to your application.

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