Vaf

1 week ago

Remote, India ProductLife Group Full time

**Role Description**:
**Role Responsibilities**:

- Adherence to ProductLife Group’s values, policies, and quality management systems.
- Perform compliance activities to meet ProductLife Group and client Quality objectives.
- Support audit requests as required.
- Provide regulatory, quality, and compliance support to clients relating to the registration/listing of pharmaceuticals, biologicals, and medical devices and the ongoing maintenance of these.
- Assist clients in responding to agency questions.
- Provide support to clients by assisting more senior members of the team with regulatory, quality, and compliance activities.
- Prepare, review, and update quality documentation.
- Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.

**Qualifications / Experience / Skills**:

- Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline.
- A minimum of 3 years of experience in Australian and New Zealand Quality or Regulatory Affairs, preferably in a commercial environment.
- Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures is preferable.
- Reasonable computer literacy.
- Proven experience dealing with a high level of confidentiality.
- Good problem-solving and project management skills.
- Ability to work to deadlines.
- Attention to detail.
- Excellent written and spoken communication and interpersonal skills.
- Interest in the practice of consulting.
- An appetite for learning and development.

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