Job Description
Key Responsibilities
Regulatory Strategy & Planning:
Develop and execute comprehensive global and regional regulatory strategies for assigned pharmaceutical development programs, ensuring alignment with R&D goals and business objectives.
Identify potential regulatory risks and propose proactive mitigation strategies.
Submissions Management:
Lead the planning, preparation, review, and submission of high-quality regulatory documents, including Investigational New Drug (IND) applications, Abbreviated New Drug Applications, 505 b(2) applicationsto regulatory agencies.
Coordinate and author the regulatory components of the Dossier
Agency Interaction:
Serve as a primary point of contact for regulatory agencies for assigned projects.
Coordinate and participate in formal meetings with regulatory authorities
Manage and track regulatory agency correspondence and commitments.
Internal Collaboration & Compliance:
Provide expert regulatory guidance and interpretation of regulations and guidelines (e.g., ICH, FDA, EMA) to R&D teams (Clinical, Nonclinical, CMC, Quality Assurance).
Review and approve R&D documentation (e.g., protocols, reports, SOPs) for regulatory compliance.
Maintain current knowledge of the global regulatory environment and communicate changes that may impact development programs.
Documentation & Archival:
Ensure all regulatory records and archives are maintained in a compliant, audit-ready state.
Job Types: Full-time, Permanent, Fresher
Pay: ₹180,000.00 - ₹200,000.00 per year
Work Location: In person
Regulatory Strategy & Planning:
Develop and execute comprehensive global and regional regulatory strategies for assigned pharmaceutical development programs, ensuring alignment with R&D goals and business objectives.
Identify potential regulatory risks and propose proactive mitigation strategies.
Submissions Management:
Lead the planning, preparation, review, and submission of high-quality regulatory documents, including Investigational New Drug (IND) applications, Abbreviated New Drug Applications, 505 b(2) applicationsto regulatory agencies.
Coordinate and author the regulatory components of the Dossier
Agency Interaction:
Serve as a primary point of contact for regulatory agencies for assigned projects.
Coordinate and participate in formal meetings with regulatory authorities
Manage and track regulatory agency correspondence and commitments.
Internal Collaboration & Compliance:
Provide expert regulatory guidance and interpretation of regulations and guidelines (e.g., ICH, FDA, EMA) to R&D teams (Clinical, Nonclinical, CMC, Quality Assurance).
Review and approve R&D documentation (e.g., protocols, reports, SOPs) for regulatory compliance.
Maintain current knowledge of the global regulatory environment and communicate changes that may impact development programs.
Documentation & Archival:
Ensure all regulatory records and archives are maintained in a compliant, audit-ready state.
Job Types: Full-time, Permanent, Fresher
Pay: ₹180,000.00 - ₹200,000.00 per year
Work Location: In person
💡 Quick Summary
Seeking a career-building opportunity? The Regulatory Affairs Specialist position is now open for candidates interested in the Fresher Jobs sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Fresher Jobs is a plus.