Director of Regulatory Affairs

Urgently Required

Director of Regulatory Affairs

Experience :  1 to 5 years

No of vacancies :  1

Job Description: The Director of Regulatory Affairs is a senior executive responsible for leading regulatory strategy, ensuring compliance with domestic and international pharmaceutical regulations, and facilitating product approvals. This role involves coordinating with regulatory agencies, managing submissions, and guiding cross-functional teams to align with regulatory requirements to achieve business goals.

Key Responsibilities: Regulatory Strategy: Develop and implement regulatory strategies to ensure timely approval and compliance of pharmaceutical products in domestic (CDSCO, Schedule M) and international markets (USFDA, EMA, MHRA, etc.).
Submission Management: Oversee the preparation, review, and submission of dossiers, NDAs, ANDAs, DMFs, and other regulatory filings.
Agency Liaison: Act as the primary point of contact with regulatory authorities, facilitating communications and addressing queries during reviews.
Compliance Monitoring: Ensure all company operations comply with applicable regulations, guidelines, and standards.
Cross-Functional Coordination: Collaborate with R&D, quality assurance, manufacturing, and marketing teams to integrate regulatory requirements into product development and lifecycle management.
Audit Preparation: Lead preparation for regulatory inspections and audits, ensuring all documentation and processes meet agency expectations.
Risk Management: Identify and mitigate regulatory risks associated with product development, manufacturing, and market launch.
Regulatory Intelligence: Monitor and interpret changes in regulatory policies, ensuring proactive updates to compliance practices.
Team Leadership: Lead and mentor the regulatory affairs team, fostering expertise and professional development.
Labeling and Packaging Compliance: Oversee the review and approval of product labeling and packaging to ensure alignment with regulatory requirements.

Education Qualifications: Minimum Requirements: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field.
Preferred: Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, or a related discipline.
Certifications: Regulatory certifications such as RAC (Regulatory Affairs Certification) are advantageous.
Experience: Extensive experience in regulatory affairs leadership roles, including a strong track record of successful submissions and approvals in domestic and international markets.

Key Attributes: Strategic Vision: Ability to develop regulatory strategies aligned with business goals.
Regulatory Expertise: In-depth knowledge of global and local pharmaceutical regulations.
Communication Skills: Proficient in interacting with regulatory agencies and cross-functional teams.
Leadership: Capability to lead and mentor teams effectively.
Analytical Thinking: Skill in interpreting complex regulatory guidelines and making informed decisions.

About the Role: The Director of Regulatory Affairs is a pivotal leadership role responsible for guiding the organization through the complex regulatory landscape of the pharmaceutical industry. This role ensures that all products meet compliance standards and are approved for marketing in domestic and international markets. The director collaborates with cross-functional teams to integrate regulatory requirements into product development, ensuring successful submissions and product launches.