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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:
Delivers Regulatory (RA) Milestones for the Netherlands, both for Drugs and Medical Devices.
Represents PH as a competent reliable partner to the local Health Authorities in assigned regulatory and market access matters.
Builds networks with national regulators (marketing authorizations, reimbursement), policy makers, local industry organizations, key opinion leaders and EMA stakeholders.
Ensures local Regulatory compliance for all assigned products.
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,
Contributing to the development of strategies that meet both regulatory and commercial objectives, contributing to the successful products’ launches.
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.
Leads the discussion on regional regulatory strategy of clinical development plans and dossier submissions
Is an active participant in EU wide Regulatory Affairs Manager networks.
Coaches Regulatory Affairs Officers, Assistants and Consultants on the job.
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:
Internal:
Who you are
Education
Experience
Skills and knowledge
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:
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.
Resources:
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