* Assess and classify low to medium complexity CMC changes for medicinal products
* Create Regulatory Strategies to support changes to BCH (Bayer Consumer Health) medicinal products
* Ensure that strategies, activities, timelines and expected outcomes are aligned with Product Supply, Development Centers, and CMCD, as appropriate
* Prepare and maintain complete and accurate medicinal product dossiers
* Ensure that appropriate data are entered into the proper data management systems
* Under direct supervision of the Team Lead, manage the timelines and deliverables for implementation of product changes
* Track Regulatory activities, and proactively identify issues and risks, alerting management as needed
* Provide information, documentation, and policy support to local regulatory affiliates to ensure fulfilment of Health Authority requirements throughout the product lifecycle
* Report status measures to the Team Head and appropriate stakeholders
* Represent LCM (Life Cycle Management) group in cross-functional activities
* Under guidance of Team Head, may support Trade Association Activities
A degree in the life sciences
* RA experience (preferably in OTC (Over The Counter) medicinal products)
* Proficiency in MS Office: Word, Excel, PowerPoint
* Ability to grow and expand regulatory knowledge
* Ability to communicate effectively in English both verbally and in writing
* Ability to work as a member of a team
* Results oriented
"At Bayer, sustainability is ingrained in our mission 'Health for all, hunger for none', driving our commitment to healthcare and agricultural innovation. We prioritise reducing our environmental footprint, enhancing our social impact, and ensuring sustainable business practices. As part of our team, you'll have opportunities to contribute to various initiatives such as achieving climate neutrality across our facilities by 2030, to improving access to healthcare and nutrition to 100 million underserved people worldwide by 2030. Join us and be part of a culture that values innovation and empowers change, as we strive to shape a healthier, more sustainable, and inclusive world."
Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee. What we offer
* Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
* 28 days annual leave plus bank holidays
* Private Healthcare, generous pension scheme and Life Insurance
* Wellness programs and support
* Employee discount scheme
* State of the art offices
* International career possibilities
* Flexible and and Hybrid working
* Help with home office equipment
* Volunteering days
* Support for professional growth in a wide range of learning and development opportunities
* We welcome and embrace diversity providing an inclusive working environment
The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.