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Regulatory Affairs Manager

4+ years
Not Disclosed
10 Nov. 11, 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, 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

Location: [Insert Location]
Department: Regulatory Affairs


Key Responsibilities

  • Regulatory Planning: Develop and implement regulatory strategies for new product registrations, license renewals, variations, deregistration, and other related regulatory activities.
  • Submissions & Approvals: Lead the preparation and submission of regulatory documents for new products, ensuring timely approvals, compliance with local and global regulations, and alignment with internal and external stakeholders.
  • Regulatory Compliance & System: Ensure all regulatory activities comply with relevant regulations and company standards. Maintain up-to-date knowledge of regulations to mitigate risks and facilitate approvals.
  • Cross-Functional Collaboration: Work closely with cross-functional teams such as Clinical, Medical Affairs, Marketing, and Legal to support product development and ensure regulatory alignment across all departments.
  • Regulatory Influence: Provide regulatory guidance to internal teams and influence decision-making to ensure regulatory objectives are met in line with business goals.

Qualifications

  • Education: Relevant graduate-level degree (e.g., Pharmacy, Pharmacology, Biology).
  • Experience: Minimum of 4+ years of experience in Regulatory Affairs within the pharmaceutical industry.
  • Skills:
    • Strong teamwork and collaboration skills.
    • Ability to think strategically and apply active, creative thinking in regulatory planning.
    • Fluency in both written and spoken English.
  • Knowledge: Familiarity with Novo Nordisk’s mission & vision and a strong understanding of the regulatory landscape in the pharmaceutical industry.

Why Join Novo Nordisk?

At Novo Nordisk, we are committed to creating an inclusive work environment that celebrates diversity. We believe that having diverse perspectives is essential to achieving our mission of improving patients' lives globally. Together, we go further. Together, we’re life-changing.


Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer. We are dedicated to creating a culture that fosters diversity and inclusion, where all employees are valued and respected.


How to Apply

To apply, please submit your CV and cover letter online by clicking the Apply button.