Job Description

Job DetailsJob Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Position Type: Full TimeSalary Range: ₹15.00 - ₹25.00 Salary/yearRole Definition:
The Team Leader (TL)/Senior Manager(SM) Regulatory Affairs (RA) is responsible for leading the strategic and operational aspects of regulatory 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 intelligence,  and adherence to global regulatory standards. The TL/SM also mentors and manages a team of RA professionals, drives process improvements, and supports cross-functional business objectives.
2. Key Responsibilities:
2.1 Regulatory Strategy & Dossier Management:
2.1.1 Lead end-to-end regulatory submissions, 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 Provide 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 global regulatory changes and evolving regulatory  requirements/or expectations and provide strategic recommendations to ensure to remain in compliance.
2.2.2 Assess the impact of regulatory changes on existing products, CMC, Efficacy, labeling, and Regulatory application.
2.3 Team & Process Management:
2.3.1 Manage, mentor, and develop a team of Regulatory Affairs professionals, allocating projects review, compilation based on priority and skill.
2.3.2 Develop training programs for team members to ensure up-to-date regulatory knowledge and high-quality output.
2.3.3 Foster a culture of compliance, efficiency, and continuous improvement through collaboration within the RA team.
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/ANDS/IND etc, but not limited to these .
2.5 Regulatory Data & Documentation Management:
2.5.1 Prepare and present periodic management reports, dashboards, and metrics for senior leadership.
2.5.2 Provide regulatory input and strategy for business planning, product launches, and product  lifecycle management .
2.5.3 Collaborate with internal stakeholders/cross functional team to support strategy, compliance, and operational excellence.
Position:
Role:  Team Lead/or Senior Manager 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 15-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).
M.PharmM.Pharma