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Regulatory Affairs Manager (New Created Position)

Regulatory Affairs Manager (New Created Position)

AllerganSan Francisco, CA, United States
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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , and Tik Tok .

Job Description

PRIMARY OBJECTIVE :

  • To manage the preparation of regulatory submissions of company products in order toobtain necessary regulatory approvals
  • To provide regulatory input on regulatory matters to company personnel.
  • This position will report to the RA Director with people management scope.

CORE JOB RESPONSIBILITIES :

  • Develop registration strategies and implement regulatory plan in accordance with strategic company objectives.
  • Manage registration of new / line extension products, variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.
  • Oversee regulatory affairs activities within the team, including regulatory submissions, approvals, and compliance.
  • Manage safety update reports, certified product details and import permits
  • Maintain contact with governmental officials of Korea MFDS to facilitate evaluation processes.
  • Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
  • Review and assess product labeling, packaging, and promotional materials for compliance with relevant regulations and codes.
  • Collaborating with cross-functional teams to identify and address regulatory compliance gaps and develop corrective actions.
  • Analyzing and interpreting complex regulatory requirements and guidelines to determine their applicability to the organization's products and operations.
  • Proactively identifying potential regulatory risks and proposing mitigation strategies to ensure compliance and minimize business impact.
  • Provide support for marketing plans and launch teams
  • Maintain good knowledge of the relevant Regulations & Code.
  • Bridge for translating regulatory strategies and goals into launch plans that drive the business
  • Manage performance of their Therapeutic Area
  • Coach and develop team members to achieve their best target
  • Shape the culture of the team
  • Serve as a Back-up to the RA Director : Act as the deputy and take on the responsibilities of the RA Director in their absence.

    • Qualifications

    EDUCATION / QUALIFICATIONS / EXPERIENCE :

  • University degree in appropriate discipline
  • More than 10 year experience in a regulatory position in the pharma industry withproven track records in driving new drug project
  • Experience in Neurology will be preferred
  • Experience in people management is a great plus
  • Must be proficient in both spoken and written English.

    • Additional Information

    AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

    US & Puerto Rico only - to learn more, visit

    US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

    #J-18808-Ljbffr

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    Regulatory Manager • San Francisco, CA, United States

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