Regulatory Associate
2 weeks ago
**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**
**Regulatory Associate**
**Position: Major Tasks**:
- Assess and classify low complexity CMC changes for medicinal products
- Create Regulatory Strategies to support changes to BCH 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 proper and timely registration of medicinal product changes in affected countries in collaboration with local Regulatory affiliates
- Ensure that all registration data are entered into the proper data management systems
- Under direct supervision of the Team Lead, manage the timelines and deliverables for regulatory submissions to Health Authorities
- 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
- Assist Regulatory Managers with activities supporting medium to high complexity changes
- Report status measures to the Team Head and appropriate stakeholders
**Position: Skills**:
- A degree in the life sciences
- Previous industry RA experience required **(preferably in OTC 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
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 and include the following list of benefits and working conditions:
- competitive salary and performance bonus
- 28 days annual leave plus bank holidays
- Private Healthcare, generous pension scheme and Life Insurance
- Employee discount scheme
- State of the art offices
- International career possibilities
- Flexible and hybrid working
**The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.**
LI-UK
Hybrid
**Location**:
United Kingdom : Berkshire : Reading
**Division**:
Consumer Health
**Reference Code**:
797814
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