Skip to main content
Post your resume and find your next job on Indeed!

Medical Affairs jobs

Sort by: -
    • As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
    • View all Alimentiv jobs - Remote jobs - Regulatory Affairs Specialist jobs in Remote
    • Salary Search: Regulatory Affairs Specialist (Australia) salaries in Remote
    • Mayne Perks: Enjoy exclusive discounts and savings.
    • Compile documentation necessary for local and overseas regulatory submissions (new product registrations,…
    • 3+ years Regulatory Affairs experience within medical devices (ANZ preferred).
    • Prepare and submit ARTG and WAND inclusion applications across all relevant…
    • Ability to identify the unmet medical, educational, and research needs at a local & regional level in the medical community.
    • Provide career development opportunities for medical information specialists.
    • Provide technical and medical information to doctors, pharmacists, and other…
    • Oher medical affairs duties as required by the medical affairs management.
    • Proactively develops and increases knowledge of medical literature, and participates…
    • Essential Experience • Advanced degree or extensive experience in regulatory affairs.
    • Monitoring and maintaining local and overseas compliance with regulatory…
    • Responsible for effectively supporting the sales revenue and product mix requirements for their.
    • Supports clinical fulfillment of company procedures in the…
    • Strong understanding of medical device technical documentation, manufacturing processes and quality management systems.
    • Education Level Bachelor's Degree.
    • Proven success in medical sales or similar B2B environment.
    • Adelaide, Australia | Full time | Field-based | R1556143.
    • The Director, Medical Affairs and Policy leads the integrated strategy and execution of post‑market clinical evidence generation, medical affairs, and…
    • Keep up-to-date with government legislation as it relates to regulatory affairs.
    • Maintain adequate records and documentation of all regulatory and scientific…
    • Experience in research ethics, research governance or regulatory affairs will be highly regarded although candidates with strong clinical trial monitoring and…
    • 2-3 years’ experience in medical information, medical affairs, or pharmaceutical industry.
    • Develop clear, balanced, evidence-based MI responses for medical…
    • Experience in an MSL, medical or research role within pharma, biotech or medical devices.
    • Strong communication skills and the ability to build credibility with…

Job Post Details

Regulatory Affairs Specialist (Australia) - job post

Alimentiv
2.5 out of 5 stars
Remote
Permanent, Full-time

Job details

Job type

  • Permanent
  • Full-time

Full job description

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Unit Management

  • Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
  • Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.

Client Services

  • As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
  • Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.

Regulatory Strategy Development

  • Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
  • Participate in specialized conferences/meetings to increase knowledge as needed.

Project Support

  • Regularly respond to registration requests and work with project teams to identify regulatory requirements.
  • Assist in the preparation of regulatory submissions and support summaries.
  • Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.

Qualifications

  • Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
  • The successful candidate will possess strong knowledge of LATAM clinical trial regulations.
  • Fluency in English and Spanish (written and verbal) required.

Working Conditions

  • Home-based
    • Accommodations for job applicants with disabilities are available upon request.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Let Employers Find YouUpload Your Resume