Regulatory Affairs Associate

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:

3–5 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