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Senior Manager, Regulatory Affairs

10+ years
Not Disclosed
10 Jan. 3, 2025
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

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We’re Growing—Grow With Us!
Are you seeking a dynamic role with daily challenges and opportunities for growth?

PharmaLex, a global leader in consulting services for the pharmaceutical industry, is specialized in drug and medical device approvals, market development, and comprehensive product lifecycle management.

We are currently looking for an experienced Senior Manager, Regulatory Affairs to join our team in Sydney, Australia (hybrid work environment).


Senior Manager, Regulatory Affairs

Location: Sydney, Australia (Hybrid)


Your Role

We offer an exciting opportunity for an experienced regulatory professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will:

  • Work with a diverse range of clients in the pharmaceutical and healthcare sectors.
  • Advise, support, and manage regulatory submissions and approvals for client products.
  • Ensure client products achieve appropriate licensing, marketing, and regulatory compliance.
  • Collaborate proactively with global, regional, and local colleagues.
  • Liaise with regulatory teams, clients, and third-party subject matter experts.

This role provides a chance to engage with innovative products and projects while supporting clients to maximize their commercial success.


Your Profile

  • Qualifications: Formal qualifications in science or a related field.
  • Experience:
    • Minimum of 10 years’ experience in regulatory affairs, with expertise in prescription medicines.
    • Extensive experience within the Australian and New Zealand regulatory environments.
    • Proven track record managing regulatory work across the product lifecycle, including Category 1 and New Medicine Applications.
    • Experience leading regulatory assessments for early pipeline products and new technologies.
  • Skills:
    • Exceptional problem-solving, critical thinking, and commercial acumen.
    • Strong communication and stakeholder management skills.
    • Ability to effectively manage and deliver multiple projects simultaneously.
  • Location: Based in Australia, with full working rights.

Why Join Us?

  • Be part of a highly regarded team recognized as specialists in the field.
  • Collaborate with senior managers, associate directors, and directors with extensive consulting experience.
  • Work in a culture that values diversity, growth, and inclusivity.
  • Enjoy flexible working options, including hybrid work and varied start/finish times.
  • Sydney-based head office with options to work from Melbourne, Canberra, or Brisbane.

Application Process

If you are interested in this exciting opportunity, please submit your application, including a cover letter, earliest possible start date, visa requirements, and salary expectations.

Contact Us:
For further information, please reach out to:
Ms/Mr. Brandenburg
Senior Manager, Human Resources Australia


Note: Applications from agencies will only be accepted by prior agreement for this specific job opportunity.


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