Senior Research Associate

Role Definition:

The Senior Research Associate(SRA) Regulatory Affairs (RA) is responsible for the strategic and operational aspects of regulatory, review, compilation, submissions, approvals, and compliance across multiple markets (i.e. USA, EU, Canada etc. but not limited to these). This role ensures timely submissions of quality applications ,approvals, robust regulatory knowledge, and adherence to global regulatory standards. The SRA also supports cross-functional business objectives.

2. Key Responsibilities:

2.1 Regulatory Strategy & Dossier Management:

2.1.1 Should have prior 7-10 years submissions experience, including new product approvals, PLCM/Supplements/ variations, Annual reports/renewals, and amendments across Global markets with competent Global Regulatory Authorities (i.e. U.S. FDA, EMA, Health Canada etc.) for Complex Solid Oral Dosage forms and Injectables.

2.1.2 Ensure all submissions meet country-specific regulatory requirements and internal quality standards.

2.1.3 Support regulatory guidance to cross-functional teams (R&D, Quality, Project Management, Purchase Team, CMO, API Vendor etc.) for product lifecycle management.

2.1.4 Track and resolve regulatory authority deficiencies to avoid delays in approvals.

2.1.5 Maintain and monitor approval timelines to ensure regulatory compliance and business continuity.

2.2 Regulatory Intelligence & Compliance :

2.2.1 Monitor and keep updated over the global regulatory changes and evolving regulatory requirements/or expectations and provide strategic recommendations to ensure to remain in compliance.

2.4 Regulatory Data & Documentation Management:

2.4.1 Ensure that all regulatory documents, submissions, and correspondence are archived in time periodically in an organized, traceable manner.

2.4.2 Maintain integrity, traceability, and accuracy of regulatory databases and electronic recods of ANDA/MAA/DCP/MRP/CP/ANDS/IND etc, but not limited to these .

2.4.3 Collaborate with internal stakeholders/cross functional team to support strategy, compliance, and operational excellence.

Position:

Role: Senior Research Associate-Global Regulatory Affairs

Industry Type: Pharmaceutical

Education

PG: M.Pharm, in Pharmaceuitics /or Regulatory Affairs

Any additional degree is preferred.

Key Skills

Regulatory Affairs

Experience: Minimum 7-10 Years of Experience in regulatory affairs with OSD/Parenteral including conventional as well as complex dosage forms in generic space (ANDA/MAA/ANDS) and/or NDA/505(b)(2).

Education

PG: M.Pharm, in Pharmaceuitics /or Regulatory Affairs

Any additional degree is preferred.

Key Skills

Regulatory Affairs

Experience: Minimum 7-10 Years of Experience in regulatory affairs with OSD/Parenteral including conventional as well as complex dosage forms in generic space (ANDA/MAA/ANDS) and/or NDA/505(b)(2).