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    Regulatory Affairs Manager

    Boehringer Ingelheim
    2+ years
    Not Disclosed
    Basel
    10 Dec. 6, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Here’s the translation and reworded version of the job posting for Regulatory Affairs Manager & Local Pharmaceutical Complaint Officer (LPCO):

    Job Title: Regulatory Affairs Manager & Local Pharmaceutical Complaint Officer (LPCO)

    Job ID: 17031

    Location: Basel, Switzerland

    About Boehringer Ingelheim

    For over 130 years, Boehringer Ingelheim has been at the forefront of innovation, developing medications that improve the health and well-being of both humans and animals. As one of the top 20 leading pharmaceutical companies globally, Boehringer Ingelheim continues to be family-owned. The company employs 52,000 people worldwide and operates in three main business areas: Human Pharmaceuticals, Animal Health, and Biopharmaceutical Contract Manufacturing. In Switzerland (Basel), approximately 100 employees work in Human Pharma and Animal Health.

    Job Overview:

    Boehringer Ingelheim is seeking an experienced Regulatory Affairs Manager & Local Pharmaceutical Complaint Officer (LPCO) to join the Regulatory Affairs team. This role is key for individuals with expertise in drug registration and complaint management who are passionate about contributing to patient health and safety.

    Responsibilities:

    • Market Authorization & Maintenance: Oversee the market approval and ongoing regulatory maintenance for human pharmaceutical products in Switzerland.
    • Local Pharmaceutical Complaint Officer (LPCO): Take on the role of LPCO, managing pharmaceutical complaints and ensuring compliance with local regulations.
    • Regulatory Submissions: Handle the preparation and submission of regulatory applications to Swissmedic (Swiss regulatory authority).
    • Regulatory Compliance: Ensure all regulatory requirements and legal guidelines are met in close collaboration with Swiss health authorities.
    • Strategic Regulatory Support: Provide strategic regulatory advice to local business units, helping navigate the regulatory landscape.
    • Complaint Management & Recalls: Manage technical product complaints and coordinate product recalls in partnership with the quality team.
    • Local & Global Committees: Participate in both local and global committees and ensure compliance in complaint and recall management.

    Qualifications:

    • Education: Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
    • Experience:
      • In-depth experience with Swissmedic regulatory submissions and approvals.
      • Familiarity with Swiss pharmaceutical law and regulatory requirements.
      • Experience in collaborating with both local and international health authorities and implementing regulatory strategies at the local level.
    • Skills:
      • Excellent communication skills and a team-oriented mindset.
      • Strong organizational skills with a structured approach to work.
      • High degree of responsibility and the ability to work independently in a dynamic, regulated environment.
      • Fluency in German and English (French or Italian is a plus).

    What We Offer:

    • Challenging & Varied Tasks: Contribute to a future-oriented company within a dynamic industry.
    • Supportive Team Environment: Work with motivated colleagues in an innovative and collaborative atmosphere.
    • Attractive Benefits: Competitive employment conditions and social insurance benefits.
    • Growth Opportunities: We prioritize the personal development of our employees because your growth is our growth.
    • Inclusive Culture: Boehringer Ingelheim fosters a diverse and inclusive environment where everyone’s perspective is valued.

    Why Boehringer Ingelheim?

    At Boehringer Ingelheim, you’ll have the opportunity to grow, collaborate, innovate, and make a meaningful impact on people's lives. Join a company that offers a global, respectful working environment focused on continuous innovation. We believe in the value of diverse perspectives and are committed to creating an inclusive culture that benefits all employees, patients, and communities.

    For more information, visit: Boehringer Ingelheim Careers.

    This role provides an exciting opportunity to take on a key position in regulatory affairs and complaint management while contributing to the success of an innovative global pharmaceutical company.

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