ProductLife Group is hiring a Regulatory Affairs Officer / Associate Consultant for its India team. This is a full-time remote opportunity for professionals with 3–4 years of regulatory affairs experience, particularly those with knowledge of Australia, New Zealand and JAPAC regulatory activities.
The role involves supporting pharmaceutical, biological and medical device registrations, lifecycle maintenance, eCTD publishing, regulatory dossier preparation and submissions to authorities such as the Therapeutic Goods Administration (TGA) and Medsafe. ProductLife Group confirms that its current career opportunities include remote positions in India and that its regulatory affairs services cover product registration and lifecycle activities across global markets.
Job Overview
| Details | Information |
|---|---|
| Company | ProductLife Group |
| Position | Regulatory Affairs Officer / Associate Consultant |
| Job Code | VAF646 |
| Location | India |
| Work Mode | Remote |
| Job Type | Full Time |
| Experience | 3–4 Years |
| Department | Regulatory Affairs |
| Qualification | Undergraduate degree in Pharmaceutical Sciences or relevant scientific discipline |
Key Roles & Responsibilities
The selected candidate will be responsible for supporting regulatory activities and client projects across international markets.
- Support registration and listing of pharmaceuticals, biologicals and medical devices.
- Assist with lifecycle maintenance of existing registrations and listings.
- Provide eCTD publishing support for regulatory submissions.
- Review, critically evaluate, prepare and submit regulatory dossiers to TGA and Medsafe.
- Assist clients in preparing responses to questions raised by regulatory authorities.
- Support senior team members with complex regulatory applications.
- Assist with regulatory project and client-management activities.
- Prepare and manage GMP clearance applications.
- Prepare, review and update quality documentation.
- Handle confidential client and regulatory information appropriately.
- Maintain accuracy while managing submission timelines and project deliverables.
These responsibilities align with ProductLife Group’s regulatory affairs work, which includes dossier preparation, lifecycle maintenance, regulatory submissions and market-specific regulatory support.
Required Qualifications
Candidates should meet the following requirements:
- Undergraduate qualification in Pharmaceutical Sciences or another relevant scientific discipline.
- Minimum 3 years of Regulatory Affairs experience.
- Experience with Australian and New Zealand regulatory activities in a commercial environment is preferred.
- Good knowledge of TGA and Medsafe legislation, regulations, guidelines and procedures.
- Strong attention to detail.
- Good problem-solving and project-management abilities.
- Excellent written and verbal communication skills.
- Ability to work effectively with deadlines.
- Ability to handle confidential information.
- Interest in regulatory consulting and willingness to learn.
- Fluent English communication skills.
Skills Required
The role is particularly suited to candidates who have experience in:
- Regulatory dossier preparation
- eCTD publishing
- Product registration and lifecycle maintenance
- TGA submissions
- Medsafe submissions
- GMP clearance applications
- Regulatory documentation
- Client coordination
- Regulatory project management
Salary & Benefits
Salary: The company has not disclosed an official salary for this vacancy. For an experienced Regulatory Affairs professional in India with around 3–4 years of experience, a realistic market-estimated range may be approximately ₹6–10 LPA, depending on skills, relevant international regulatory experience and the final compensation offered by the employer.
Potential advantages of the opportunity include:
- Remote work opportunity
- Exposure to Australia, New Zealand and JAPAC regulatory markets
- Work involving pharmaceuticals, biologicals and medical devices
- International client and regulatory exposure
- Consulting-oriented professional experience
- Opportunities for learning and career development
ProductLife Group highlights flexible/hybrid working, international projects and continuous learning among its workplace benefits.
Who Can Apply?
This opportunity is intended for experienced Regulatory Affairs professionals who satisfy the stated experience requirement. Candidates with pharmaceutical sciences or relevant scientific backgrounds and experience in international regulatory affairs may find the role particularly relevant.
No separate fresher eligibility is stated in the provided job description, so this position should not be treated as a fresher opening.