Regulatory Affairs Senior Manager

Cencora; Sevilla; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A healthcare consulting firm is seeking a Senior Manager Regulatory Affairs to join their remote team based in Spain. The role involves managing client relationships and leading regulatory processes while applying your expertise in regulatory affairs for both human and veterinary products. Ideal candidates should possess a degree in Life Science and demonstrate excellent communication skills in English and Spanish. Full-time position available with competitive benefits.

Formación

• Proven professional experience in regulatory affairs.
• Extensive knowledge of regulatory processes and systems.
• Strong problem-solving ability in complex situations.

Responsabilidades

• Develop and maintain strong client relationships.
• Prepare and compile documents for regulatory affairs projects.
• Communicate with clients and health authorities.
• Plan and execute projects according to KPIs.
• Lead and mentor direct reports.

Conocimientos

Fluent in English and Spanish

Excellent written and verbal communication skills

Ability to manage internal and external relationships

Analytical and systematic work style

Operational support and project delivery

Educación

University degree in Life Science

Descripción del empleo

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Pharmalex, a Cencora company, is looking for a

Senior Manager Regulatory Affairs

to join the team, remotely based in Spain.

Key Responsibilities :

1. Develop and maintain strong client relationships and help drive opportunities for increased service support to Line Manager.
2. Participate in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations), including medical devices, cosmetics, food supplements, and herbal products.
3. Prepare, review, and compile documents within the framework of regulatory affairs projects.
4. Communicate with clients and Health Authorities.
5. Support scientific advice procedures and represent clients with health authorities.
6. Plan and execute client projects in accordance with KPIs. Coordinate project teams with colleagues and external partners.
7. Provide general guidance (consultancy) to colleagues and clients regarding Regulatory Strategy and Procedure Management.
8. Develop and maintain personal regulatory knowledge, apply it to client projects, and share actively with colleagues.
9. Present seminars and lectures for colleagues, clients, and professional audiences.
10. Contribute actively to department expertise.
11. Support VDC strategy implementation and optimization.
12. Optimize internal processes and ensure compliance.
13. Provide operational support to colleagues daily.
14. Contribute to commercial, marketing, and business development activities, including proposal input.
15. Oversee project delivery within budget and resolve invoicing queries.
16. Provide on-site regulatory support to GCS clients as agreed with the Head of VDC REG.
17. Lead and coach direct reports; conduct evaluations and personal development meetings.
18. Monitor utilization, capacities, and capabilities of team members and escalate issues as needed.

Education & Experience :

• University degree in Life Science.
• Proven professional experience in the area of responsibility.
• Extensive knowledge of the discipline or department, capable of solving complex problems, with a strong understanding of the business.

Minimum Skills, Knowledge & Ability requirements :

• Translate strategic goals into tactical goals and implement milestones.
• Define escalation processes.
• Work in a structured, analytical, systematic, and independent manner.
• Prioritize effectively.
• Lead project reengineering activities and manage change processes.
• Identify up / cross-selling opportunities proactively.
• Lead, mentor, manage, and motivate staff.
• Manage internal and external relationships at senior levels.
• Discuss and align mid-term collaboration goals.
• Excellent written and verbal communication skills.
• Capable of addressing critical issues and proposing solutions to decision-makers. Good presentation skills and confident demeanor.
• Fluent in English and Spanish.

What Cencora offers

Benefits outside the US may vary by country and will be aligned to local practices. Eligibility and effective date may differ for some benefits and team members under collective bargaining agreements.

Full-time position.

Affiliated Companies

PharmaLex Spain S.L.U.