Instagram
youtube
Facebook

Senior Manager, Regulatory Affairs

2+ years
Not Disclosed
10 Oct. 24, 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

We are Growing, Grow with Us!
Are you seeking a dynamic company where new challenges and opportunities are part of everyday life? Pharmalex is your next career opportunity! As one of the leading service providers for the pharmaceutical industry globally, we specialize in all aspects of drug and medical device approval, market development, and effective product maintenance.

Position: Senior Manager, Regulatory Affairs

Location: Sydney, Australia (Hybrid)

Your Role

We have 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, primarily in the pharmaceutical and healthcare sectors. Your main objective will be to maximize client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance for their products.

Key responsibilities include:

  • Advising, supporting, and managing regulatory submissions and approvals.
  • Liaising with clients, regulatory teams, and third-party subject matter experts.
  • Collaborating proactively with global, regional, and local colleagues.

Your Profile

  • Qualifications:
    Formal qualifications in science or a related field.

  • Experience:
    Minimum of 10 years in regulatory affairs for prescription products, either in industry or consulting.

  • Expertise:
    Recognized technical expert within the Australian regulatory environment, with a strong track record across the product lifecycle. Extensive experience with prescription medicines in Australia and New Zealand, including Category 1 and New Medicine Applications, is essential.

  • Skills:
    Strong problem-solving abilities, critical thinking, commercial mindset, and exceptional communication and stakeholder management skills.

  • Project Management:
    Ability to manage and deliver multiple projects simultaneously in a diverse and challenging environment.

What We Offer

By joining the Pharmalex Australia team, you'll be part of a group renowned for its expertise. You'll work closely with experienced Senior Managers, Associate Directors, and Directors who have extensive consulting experience. We foster a culture where everyone feels valued and heard, promoting skill-building and career growth.

Our head office is located in St Leonard’s, Sydney, NSW, but we also consider candidates from Melbourne, Canberra, or Brisbane. We offer flexible working options, including varying start and finish times and hybrid working arrangements. We celebrate diversity and welcome experiences from various countries and settings.

How to Apply

Please submit your application, including a cover letter. Applicants must be based in Australia and have full working rights.

If you're interested in joining our Pharmalex team for this exciting opportunity, we look forward to receiving your application documents, including your earliest possible starting date, any visa requirements, and salary expectations.

For further information, please don’t hesitate to contact:

Ms/Mr. Brandenburg
Senior Manager, Human Resources Australia

Agencies only by prior agreement for the specific job opportunity.