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Manager Global Regulatory Affairs

5+ years
$140K/yr - $150K/yr
15 June 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Manager Global Regulatory Affairs

Location: Princeton, New Jersey

About the Job:

Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, and paid PTO. This position offers growth opportunities, great pay, and an excellent work environment.

Why You Should Apply:

  • Growth Opportunities
  • Great Pay
  • Excellent Work Environment
  • Great Benefits
  • Vacation Days

Essential Requirements and Duties:

Qualifications:

  • Bachelor's Degree required.
  • Minimum of 5+ years Regulatory Affairs experience.
  • Global Regulatory Affairs Experience in the pharmaceutical or biotechnology industry.
  • Experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs.
  • Knowledge of EU GMP requirements.

Responsibilities:

  • Regulatory Strategy:

    • Develop and execute regulatory strategies to achieve successful product registration and commercialization.
    • Identify improvements and efficiencies to Regulatory Affairs.
  • Compliance Expertise:

    • Provide expert guidance on specific controls.
    • Ensure adherence to cGMP (current Good Manufacturing Practice) and other relevant standards.
  • Cross-Functional Collaboration:

    • Work closely with cross-functional teams to integrate regulatory requirements into manufacturing processes.
  • Regulatory Representation:

    • Represent the company in interactions with regulatory authorities.
    • Lead discussions as needed.
  • Product Support:

    • Provide regulatory affairs support for sustaining products, including assessments and change management.
  • Surveillance and Analysis:

    • Engage in regulatory surveillance activities.
    • Provide regular analysis to support existing and future processes.
  • Document Management:

    • End-to-end regulatory submission and document management experience.
  • Internal Policy Reviews:

    • Support internal policy reviews for global regulatory guidance and regulations.

Skills:

  • Demonstrated Good Leadership Skills
  • Excellent Verbal and Written Communication Skills

Contact Information:

Jasleen Kaur
Email: jasleen@ajuliaexecutivesearch.com

About Ajulia Executive Search:

Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal, and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and a full comprehensive benefits package.