Job Description
Mode of Work - Hybrid
Shift - 6AM-3PM IST
Roles & Responsibilities:
- Provide regulatory intelligence for global product and project regulatory strategies by performing assessments of CMC dossiers/changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies determined by the BWG business unit QORA by leading the development, authoring and review of CMC submission components and documentation to support pre and post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Liaise with external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle.
- Identify and communicate potential regulatory issues to QORA business unit leads, as appropriate.
- Review of the Dossiers as per the current prescribed guidelines of the Respective regulatory authorities.
- Handling and responding to all the product specific queries arising from various countries.
- Preparation of Technical Packages checklist, SPC, tender documents WHO GMP Stability
- Review of QA documents, documents required for regulatory agencies and Package insert labelling information.
- Compilation of Dossiers (CTD, ACTD, Regional) as per country specific MOH guidelines.
- Preparation and Review of BFIF as per EU guidelines.
- Compilation of Deficiencies response to the Agency.
Years of Experience:
- 35 years of relevant experience with regulatory submissions, CMC documentation, and direct interaction with health authorities is highly valued.
Key skills:
- Knowledge of global regulatory requirements and product registration processes (TGA, Medsafe NZ, FDA, EMA, MOH, ICH guidelines, GMP, etc.)
- Proficiency with Regulatory Information Management Systems (RIMS) and document management tools (e.g., eCTD)
- Project management and ability to meet deadlines
- Adaptability to changing regulations and priorities
- Excellent written and verbal communication
- Strong attention to detail and organizational skills
- Analytical and problem-solving skills
- Ability to work collaboratively in cross-functional teams
- Familiarity with Good Manufacturing Practices (GMP) and quality systems
- Strong computer skills, including Microsoft Office Suite and regulatory database
