RA Manager (m/f/d)

☞ Bayer

View: 130

Update day: 29-03-2024

Location: Basel Basel-Stadt BS

Category: Other

Industry: Chemical Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

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.RA Manager (m/f/d)Role Purpose:Responsible for creation and implementation of regulatory strategies and dossiers to support the expansion of Bayer Consumer Health (BCH) products into new markets. Ensures that regulatory dossiers reflect the latest and most appropriate information, and that this data is accessible to local regulatory affiliates. Drives assigned products through the registration process, where required, ensuring timely submission. Identifies risks and mitigation plans to achieve first cycle approval.Role tasks and responsibilities:
  • Proactively identify product expansion opportunities that will positively impact the Consumer Health business.
  • Develop, align, and implement product regulatory strategies to expand existing BCH products into new markets in close collaboration with GCBU, Product Supply, R&D and other RMSC (Regulatory, Medical, Safety & Compliance) colleagues.
  • With minimal supervision of the Team Lead, manage the timelines and deliverables for preparation of accurate and timely Regulatory Dossiers for simple projects.
  • Under direct supervision of the Team Lead, manage the timelines and deliverables for preparation of accurate and timely Regulatory Dossiers for moderately complex projects. Accountable for the final content.
  • Submit dossiers to global Health Authorities, as required.
  • Develop response strategy for requests for additional information, including deficiency letters. Accountable for the final content
  • Proactively identify potential regulatory issues and design/execute mitigation plans.
  • Represent CH RA Product Expansion on cross functional and regulatory project teams.
  • Ensure that all registration data are entered into the proper data management systems
  • Track Regulatory activities, and proactively identify issues and risks, alerting management as needed
  • Report status measures to the Team Lead and appropriate stakeholders
  • Under guidance of Team Lead, may support Health Authority Meeting preparation and Trade Association Activities
Who are you:
  • A degree in the life sciences (post-graduate degree is preferred but not required).
  • At least 2 years relevant RA experience
  • Knowledge of European or International consumer product legislation
  • Knowledge / experience in project management
  • 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
YOUR APPLICATIONBayer 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.Bayer is committed to providing barrier-free access and support-facilities for individuals with disabilities - during the application process and beyond. Applicants with disabilities are encouraged to request any support / equipment they may need via the contact information below.Location:Switzerland : Basel-City : BaselDivision:Consumer HealthReference Code:781972
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Deadline: 13-05-2024

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