Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. 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.
Regulatory Affairs Manager, Nutritional & Digestive Health, Global Category team
The Regulatory Affairs Manager NDH RA Category is assigned a portfolio of products. For each product, they are responsible for:
Supporting proper and timely new product registration in identified countries
Ensuring that product dossiers are properly prepared, maintained, and accessible
Aligning activity and effort with the New Product Development (NPD) regulatory strategy
Ensuring that all registration data are entered into the proper data management systems
Under direct supervision of the NDH RA Category head or designee, they will manage timelines and deliverables for Regulatory Procedure submissions to Health Authorities. In doing so, carries out or oversees the following activities:
Ensuring that activities, plans, strategies, and outcomes are aligned with New Product Development (NPD)cross-functional teams, Global Regulatory CMC, local and regional regulatory teams, RA Life Cycle Management team and Product Supply as appropriate.
Manages the preparation of registration dossiers related to assigned NPDs and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of Category teams management as necessary
With guidance from NDH Category head or designee, liaise with Drug Safety and Medical to assist local countries in substantiating claims
Implement appropriate Bayer Consumer Care, RMSC and Regulatory Affairs business policies, processes and standard operating procedures
Under the guidance of NDH Category head, collaborates with Regulatory Affiliate Specialists to ensure timely completion of documentation to support the registration process.
Regularly reports status measures to the NDH Category head, NPD cross-functional project team and appropriate stakeholders
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
- Experience with food supplements/natural products is preferred
- Ability to articulate and formulate solutions to regulatory issues
- Proficiency in MS Office: Word, Excel, PowerPoint
- Willingness to grow in leadership capabilities
- Proficiency 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
Are you up for the challenge? If so, please apply below.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 471761
Functional Area: Regulatory Affairs