Fortrea, a leading global clinical research and regulatory services provider, is hiring Regulatory Operations Associate II in Mumbai, India. This full-time role offers the chance to work on global submissions, regulatory CMC documentation, packaging, labeling, and product lifecycle management. If you are passionate about regulatory affairs, quality compliance, and pharmaceutical product development, this is an excellent opportunity to grow your career with an industry leader.
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Key Responsibilities
As a Regulatory Operations Associate II, you will:
- Prepare, compile, and review product quality (CMC) and regulatory documents for global submissions (US, EU, Japan, ROW).
- Create, revise, and approve raw material and packaging specifications.
- Coordinate with cross-functional teams for change control, OOS, OOT, and product-related documentation.
- Support financial data management, supplier data, and purchase order creation.
- Assist in global labeling document updates, stability data evaluation, and dissolution profile reviews.
- Conduct literature surveys and prepare regulatory documents for excipients, APIs, and drug products.
- Manage supplier agreements for packaging development projects and commercial specification updates.
- Track metrics, perform quality checks, and escalate unresolved issues.
- Mentor and train new associates while ensuring compliance with GxP, ICH, and regulatory guidelines.
Required Qualifications
- Education:
- Bachelor’s in Pharmacy, Science, Engineering, Packaging, Polymer, Printing, or equivalent.
- Advanced degrees (M.Pharm, PhD, or PG Diploma in Packaging/Regulatory Affairs) are preferred.
- Experience:
- 2–5 years in Regulatory Affairs, Quality Assurance, Analytical Sciences, Packaging, or Pharmaceutical Development.
- Skills:
- Strong Microsoft Office and document management proficiency.
- Knowledge of regulatory requirements, GxP, ICH-GCP guidelines.
- Excellent organizational, analytical, and communication skills.
Benefits of Joining Fortrea
- Opportunity to work on global regulatory submissions and product lifecycle management.
- Exposure to cross-functional pharmaceutical operations.
- Collaborative and growth-oriented work environment.
- Competitive salary package.
- Potential for travel and global project exposure.
Application Process
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