Regulatory Specialist for Consumer Health

1 month ago


Reading, Reading, United Kingdom Bayer AG Full time
Job Summary

We are seeking a skilled Regulatory Specialist to join our Consumer Health team. As a key member of our regulatory affairs department, you will be responsible for assessing and classifying low to medium complexity CMC changes for medicinal products.

You will create regulatory strategies to support changes to BCH (Bayer Consumer Health) medicinal products, ensuring that strategies, activities, timelines, and expected outcomes are aligned with Product Supply, Development Centers, and CMCD, as appropriate.

Your primary duties will include preparing and maintaining complete and accurate medicinal product dossiers, ensuring that appropriate data are entered into the proper data management systems, and managing the timelines and deliverables for implementation of product changes under direct supervision.

Main Responsibilities
  • Candidate Assessment: Evaluate candidate qualifications and assess their ability to grow and expand regulatory knowledge.
  • Regulatory Compliance: Ensure compliance with relevant regulations and guidelines, providing information, documentation, and policy support to local regulatory affiliates to ensure fulfillment of Health Authority requirements throughout the product lifecycle.
  • Strategy Development: Create and implement effective regulatory strategies to support product changes, working closely with cross-functional teams to align timelines and deliverables.
Requirements
  • Education: A degree in the life sciences is required.
  • Experience: RA experience, preferably in OTC (Over The Counter) medicinal products, is necessary.
  • Skills: Proficiency in MS Office: Word, Excel, PowerPoint, and strong communication skills are essential.
What We Offer
  • A competitive compensation package consisting of an attractive base salary and annual bonus, with individual bonuses granted for top performance awards.
  • 28 days annual leave plus bank holidays, private healthcare, generous pension scheme, and Life Insurance.
  • Wellness programs and support, state-of-the-art offices, international career possibilities, flexible and hybrid working, help with home office equipment, and support for professional growth through various learning and development opportunities.


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