Regulatory Affairs Manager

Cencora; Madrid; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

Cencora, a leading global service provider for the pharmaceutical industry, seeks a Regulatory Affairs Manager to join their team. This full-time role involves executing critical regulatory tasks ensuring the compliance of medicines and medical devices. Candidates should have a background in Life Science and proven expertise in regulatory affairs for both human and veterinary products.

Servicios

Benefits vary by country, aligned with local practices

Formación

• Established experience in regulatory affairs for human and veterinary products.
• Proficiency in client communication and regulatory processes.
• Ability to support and lead projects effectively.

Responsabilidades

• Develop and maintain strong client relationships.
• Prepare and compile documents for regulatory affairs.
• Support scientific advice procedures with health authorities.

Conocimientos

Proofreading

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

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!

Cencora Pharmalex is one of the leading service providers for the pharmaceutical industry globally, specializing in all aspects of drug and medical device approval, market development, and effective product maintenance.

Position: Regulatory Affairs Manager

The Regulatory Affairs Manager will be responsible for executing operational tasks within the Regulatory Strategy & Procedure Management Practice Area, requiring established experience and scientific expertise in human and veterinary medicinal products.

Responsibilities include:

1. Developing and maintaining strong client relationships and exploring opportunities for increased service support.
2. Participating in regulatory processes to obtain and maintain marketing authorizations for human and veterinary medicinal products, medical devices, cosmetics, food supplements, and herbal products.
3. Preparing, reviewing, and compiling documents for regulatory affairs projects.
4. Communicating with clients and health authorities.
5. Supporting scientific advice procedures and representing clients with health authorities.
6. Planning and executing client projects in accordance with KPIs, and coordinating project teams with colleagues and external partners.
7. Providing guidance to colleagues and clients on Regulatory Strategy and Procedure Management.
8. Developing and sharing regulatory intelligence and expertise.
9. Presenting seminars and lectures for colleagues, clients, and professional audiences.
10. Supporting the implementation and optimization of VDC strategy.
11. Contributing to internal process improvements.
12. Applying advanced knowledge and practical skills in the field of responsibility.
13. Holding a university degree in Life Science.

Additional requirements:

1. Ability to implement tactical goals and prioritize tasks effectively.
2. Structured, analytical, and independent working style.
3. Problem-solving skills and pragmatic solutions development.
4. Ability to train and support junior colleagues and lead small projects.
5. Managing relationships with internal teams and clients.
6. Excellent communication and presentation skills in English and the local language.

What Cencora offers

Benefits vary by country and are aligned with local practices. Eligibility and effective dates may differ for some benefits, especially under collective bargaining agreements.

Full-time position.

Affiliated Companies

PharmaLex Spain S.L.U.

Equal Opportunity Employment

Cencora is committed to providing equal employment opportunities and prohibits discrimination and harassment. We also provide reasonable accommodations for individuals with disabilities during the employment process. To request accommodations, contact us at 888.692.2272 or via email.

Required Experience:

Manager

Key Skills:

Proofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills

Employment Details:

• Type: Full-Time
• Experience: Years
• Vacancy: 1