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Regulatory Affairs Manager

Geplaatst 26 mrt. 2024
Werkervaring
5 tot 7 jaar
Full-time / part-time
Full-time
Functie
Soort opleiding
Taalvereisten
Engels (Vloeiend)
Nederlands (Vloeiend)

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At Bayer we are looking for a Manager Regulatory Affairs for our Pharma division in Mijdrecht, the Netherlands.

The position has responsibility for assigned Regulatory Affairs activities for Bayer Pharma projects in the Netherlands in order to achieve and maintain registrations in line with the short-term and

long-term strategic and commercial objectives of the Division. The Regulatory Affairs Manager bears responsibility for business protection activities, plays a strategic role in RA EU region and represents the Regulatory Affairs department in matters of his or her assigned therapeutic area. RA experience in women health or oncology or cardiovascular and ATMP is an advantage. The Regulatory Affairs Manager may also act as coach for other regulatory personnel, such as Regulatory Affairs Officers, Assistants and Consultants. You report to the Head Regulatory Affairs & QP.

Your major tasks and responsibilities:

  1. Delivers Regulatory (RA) Milestones for the Netherlands, both for Drugs and Medical Devices.

  2. Represents PH as a competent reliable partner to the local Health Authorities in assigned regulatory and market access matters.

  3. Builds networks with national regulators (marketing authorizations, reimbursement), policy makers, local industry organizations, key opinion leaders and EMA stakeholders.

  4. Ensures local Regulatory compliance for all assigned products.

  5. Regular monitoring of the submission status with the authorities, contributing to the preparation of answers to deficiency letters and other Authority requests in cooperation with GRS or EPM,

  6. Timely implementation of approved labeling and CMC changes into the packaging materials according to SOP and the local legislation.
  7. Open and transparent communication with the local Authority, prompt reactions to their requests.
  8. Contributing to the development of strategies that meet both regulatory and commercial objectives, contributing to the successful products’ launches.

  9. Contributes actively to design and assessment of European Regulatory Scientific Advice and Submission strategies as EU Regulatory Affairs Manager (EURAM) for assigned products. As EURAM you play a strategic role in the development of new products.

  10. Leads the discussion on regional regulatory strategy of clinical development plans and dossier submissions

  11. Presents European Regulatory strategy to European Management teams for endorsement
  12. Evaluates the clinical development plan to ensure that it supports the proposed labelling claims
  13. Is an active participant in EU wide Regulatory Affairs Manager networks.

  14. Coaches Regulatory Affairs Officers, Assistants and Consultants on the job.

  15. Represents Bayer Pharmaceuticals as a competent reliable partner to the local Health Authorities and at Stakeholder meetings / workshops with European Medicines Agency as needed.

Work relations

External:

  • Health Authorities, Industry associations, Key Opinion Leaders

Internal:

  • Local: Close cooperation with Country Commercial Lead, Business Unit Manager, Product Manager, Medical Director, Medical Advisor, Pharmacovigilance Country Head.
  • Global: Global Regulatory Affairs: Head of RA Europe, Global Regulatory Strategist, Global Labelling Manager, EPM managers for marketed products, Regulatory Affairs Managers/Officers in the other EU countries
  • External and internal legal experts, regulatory consultants.

Who you are

Education

  • University degree or equivalent in pharmacy, chemistry, biological sciences or medicine, such as Ph.D., Pharm.D. or equivalent

Experience

  • Five years’ experience in successfully managing registration projects and direct contact with regulatory agencies
  • Experience with CP procedures, Women’s health, Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP). Preferably ATMP projects.

Skills and knowledge

  • Knowledge of Advanced Therapy Medical Products (ATMP) and the use of digitalization in Regulatory Affairs
  • Strong networking skills: Active participation in industry association working groups and professional organizations (national or regional, f.i. EMA)
  • Ability to communicate effectively, with proven negotiating skills, convincing presentation skills
  • Leadership skills
  • Analytical skills
  • Project management skills
  • Detailed understanding of structure, operating procedures and policies of the national agencies
  • Detailed knowledge of structure, operating procedures and policies of Notified Bodies in the EU
  • Fluent in English and Dutch, both written and spoken. Knowledge of other foreign languages (German) is desirable
  • Detailed knowledge of drug development process
  • High degree of accuracy and reliability
  • Able to build trust

What Bayer offers you?

At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. Bayer employees benefit from good employment conditions, such as:

  • Excellent salary including 8% holiday allowance
  • Performance bonus and 13th month
  • 34 vacation days
  • International development opportunities
  • Pension plan with only 4% own contribution
  • Team of enthusiastic, professional and driven colleagues

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power.

Chemie
Utrecht
15.000 medewerkers