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Regulatory Affairs Manager - Adc

13+ years
Not Disclosed
10 Nov. 25, 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

Job Title: Regulatory Affairs Specialist

Company: Abbott

Abbott is seeking an experienced Regulatory Affairs Specialist to join our team, contributing to regulatory processes that ensure compliance and support the lifecycle management of innovative products. This role involves working under limited supervision and applying subject matter expertise in regulatory affairs to drive approvals and maintain compliance for medical devices, drugs, or biologics.


Main Purpose of Role

As an experienced professional, the Regulatory Affairs Specialist is responsible for preparing regulatory submissions, liaising with regulatory agencies, and providing guidance throughout the product lifecycle to ensure compliance with applicable regulations.


Main Responsibilities

  1. Regulatory Submissions and Approvals

    • Prepare and manage product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
    • Collaborate with regulatory agencies to expedite the approval process for pending registrations.
    • Ensure timely approval of new products and maintain continued approval for marketed products.
  2. Lifecycle and Compliance Support

    • Serve as the regulatory liaison throughout the product lifecycle.
    • Participate in product plan development, implementation, and regulatory strategy formulation.
    • Address risk management and chemistry manufacturing control (CMC) requirements.
  3. Internal and External Communication

    • Act as a regulatory representative to internal teams, including marketing and research, and external regulatory bodies.
    • Advise development and marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory requirements.
  4. Strategy and Guidance

    • Provide insights into regulatory pathways and strategies to ensure compliance and streamline product approval processes.
    • Interpret and apply appropriate regulations and provide feedback to support business objectives.

Qualifications

Education

  • Associate's Degree or equivalent, with approximately 13 years of experience in a related field.

Experience and Skills

  • In-depth knowledge of regulatory affairs processes and requirements.
  • Experience in product registration, regulatory strategy, and lifecycle management.
  • Ability to work independently with limited supervision while applying subject matter expertise effectively.
  • Strong communication and organizational skills, with the ability to liaise across internal teams and with regulatory agencies.

Why Join Abbott?

Be a part of a globally recognized leader in healthcare, where your expertise contributes to the development and approval of life-changing technologies and products. At Abbott, you’ll find opportunities for professional growth, a collaborative work environment, and a mission-driven culture dedicated to improving lives worldwide.