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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.

 

Senior RA Manager - Nutritional & Digestive Health 

 

Hybrid role - 1-2 days a week on site at Reading, Berkshire.

Position: Major Tasks:

 

The Senior Regulatory Affairs Manager NDH has assigned portfolio of new and existing products.

 

For each product, he/she is responsible for:

• Ensuring proper and timely registration in all countries in collaboration with affiliates

• Managing maintenance of worldwide marketing authorizations within I&D Nutritional Unit portfolio

• Ensuring that product dossiers are properly prepared, maintained, and accessible

• Ensuring that all registration data are entered into the proper data management systems

• Under minimal supervision of the NDH CPI Lead, he/she will manage timelines and deliverables for regulatory procedure submissions to Health Authorities. In doing so, he/she carries out or oversees the following activities:

• Ensuring that activities, plans, strategies, and outcomes are aligned with cross functional team responsible for New Product Development (NPD) team as appropriate

• 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 R&D Nutritional or DH Unit management as necessary

 • Provides information, documentation or policy support to local regulatory affiliates to enable fulfillment of health authority requirements throughout the product lifecycle

 • Liaise with Drug Safety and Medical to assist local countries in substantiating claims

• Implements and follows appropriate Bayer Consumer Health and RMSC policies, processes and standard operating procedures

• As assigned by the NDH CPI Lead, provides regulatory expertise to and oversees the work of Regulatory Specialist supporting the aligned products

• Regularly reports status measures to the NDH CPI Lead, and appropriate stakeholders

• Under the guidance of NDH CPI Lead prepares and participates in Health Authority meetings

• Additionally, the Senior Manager can be delegated by the NDH CPI Lead to participate as regulatory expert in mergers and acquisitions performing the regulatory due diligence on dossiers.

 

 

Position: Skills:

• A degree in the life sciences

• Post graduate degree is preferred but not required

• At least 5 years of experience in comparable position

• Proven regulatory experience in consumer health care

•Experience in registration of food supplements is preferred

• Experience in European regulatory procedures; National, Mutual Recognition, and Decentralized

 • Demonstrated ability to articulate and formulate solutions for regulatory issues

• Proficiency in MS Office: Word, Excel, PowerPoint

• Ability to expand regulatory procedure knowledge to include additional regions

• Ability 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

 

 

Your application:

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
  • International career possibilities
  • Flexible working

 

Are you up for the challenge? If so,  please apply below.

#LI-UK

 

 

 

Location:

Consumer Health 

 

Division:

Consumer Health 

 

Reference Code:

716946 


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