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:

• 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