Last Update: Apr 11, 2022
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Regulatory Affairs Manager - Nutritional & Digestive Health LCM&E
The Regulatory Affairs Manager is assigned a portfolio of products.
For each product, they responsible to
- Ensure proper and timely registration in all countries in collaboration with affiliates
- Manage maintenance of worldwide marketing authorizations
- Ensure that product dossiers are properly prepared and maintained
- Align activity and effort with the regulatory strategy
- Ensure that all registration data are entered into the proper Data management systems
- Under direct supervision of the Therapeutic Area Head, they will manage timelines and deliverables for Regulatory Procedure submissions to Health Authorities.
In doing so, they carry out or oversees the following activities
- Ensuring that activities, plans, strategies, and outcomes are aligned with Product Supply Consumer Care, and/or CMCD, Medical Affairs, Affiliate specialists, Local regulatory affairs and GDS.
- Manages the preparation of registration dossiers related to Assigned products and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of management as necessary.
- Provides information, documentation or policy support to local regulatory affiliates to enable fulfilment of health authority requirements throughout the product lifecycle.
- Implement and follow appropriate Bayer Consumer Health and business policies, processes and standard operating procedures.
- Regularly reports status measures to the Therapeutic Area Head and appropriate stakeholders.
- Perform CMC activities for products under their responsibilities.
Value Added to Company Success
The Regulatory Affairs Manager adds business value by ensuring that each of the products to which they has been assigned are approved in a timely and appropriate manner and ensuring that all registrations are compliant. This enables faster time to market and supports the overall brand strategies.
Qualifications, Experience and Skills
- A degree in the life sciences
- Experience in comparable position
- Proven regulatory experience in consumer health care
- Knowledge of European regulatory procedures; Mutual Recognition, Decentralized and National is preferred
- Experience in registration of food supplements is preferred
- Ability to articulate and formulate solutions to regulatory issues
- Proficiency in MS Office: Word, Excel, PowerPoint
- Ability to expand regulatory procedure knowledge to include additional regions
- Willingness to grow in leadership capabilities
- Ability to communicate effectively in English both verbally and in writing
- Ability to work as a member of a team
- Results orientated
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.
Reward is important to us, employees benefit from excellent employment conditions, such as:
- competitive salary and performance bonus
- 25 days annual leave plus bank holidays
- Private Healthcare, generous pension scheme and Life Insurance
- Employee discount scheme
- State of the art offices (award winner for British Council for Offices, Best Fit Out Category 2018)
- International career possibilities
- Flexible working
#LI-UK
Location:
United Kingdom : Berkshire : Reading || United Kingdom : Cambridgeshire : Cambridge
Division:
Consumer Health
Reference Code:
605476
