Leaman Life Sciences
Location
Delhi | India
Job description
My client are seeking a highly skilled Regulatory Affairs Team Lead to join their dynamic team in India. The ideal candidate will have extensive experience in regulatory affairs, particularly in handling DCP submissions, and possess comprehensive knowledge of international pharmaceutical regulations.
Key Responsibilities: Lead and manage the Regulatory Affairs team, providing guidance, support, and mentorship to ensure successful project execution and regulatory compliance. Oversee the preparation, submission, and maintenance of regulatory dossiers for DCP submissions, ensuring accuracy, completeness, and adherence to regulatory requirements. Develop and implement regulatory strategies for product registration and lifecycle management, collaborating closely with cross-functional teams to achieve regulatory milestones and objectives. Act as the primary point of contact for regulatory agencies, representing the company in regulatory interactions, meetings, and negotiations. Provide regulatory guidance and support to internal stakeholders, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment with regulatory requirements and business objectives. Contribute to the development and implementation of regulatory processes, policies, and standards to enhance efficiency, compliance, and regulatory excellence within the organization. Qualifications: Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field. Advanced degree preferred. Minimum 10 years of experience in regulatory affairs within the pharmaceutical industry Comprehensive understanding of regulatory requirements and processes for pharmaceutical product registration and lifecycle management in India and key international markets. Experience in preparing, submitting, and managing regulatory dossiers for DCP submissions, including Module 3. Familiarity with regulatory guidelines and requirements of regulatory authorities such as CDSCO, EMA, FDA, and ICH. Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively to diverse stakeholders.Job tags
Salary
