Officer - Regulatory Affairs

Required Qualifications & Skills:

Education:

• A bachelor's degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Chemistry, diploma in Regulatory Affairs .
• Experience:
• 3 to 4 years of experience in a regulatory affairs role within the pharmaceutical or API industry is essential.
• Familiar with regulatory submission systems .

Key Skills:

• Regulatory Knowledge: A strong and current understanding of global regulatory frameworks, including ICH guidelines, US FDA regulations (e.g., 21 CFR), European regulations (e.g., EudraLex), and regional-specific requirements.
• Communication Skills: Excellent written and verbal communication skills are necessary for drafting clear and concise regulatory documents, as well as for liaising with regulatory agencies and internal teams.
• Analytical and Problem-Solving Skills: The ability to analyze complex data, interpret regulations, and devise solutions to regulatory challenges is crucial.
• Teamwork: The ability to collaborate effectively with different departments to gather the required information for submissions.

Key Responsibilities:

• Dossier Preparation and Submission:
• Prepare and submit regulatory dossiers for new APIs, renewals, and variations to regulatory agencies (e.g., US FDA, European Medicines Agency (EMA), CDSCO in India, etc.).
• Compile, review, and manage all relevant documents, including the Chemistry, Manufacturing, and Controls (CMC) section, analytical data, stability studies, and process validation reports.
• Ensure all submissions are complete, accurate, and meet the specific requirements of each regulatory body.
• Regulatory Compliance and Strategy:
• Serve as the primary point of contact and liaison with regulatory authorities.
• Respond to queries and deficiency letters from agencies in a timely and comprehensive manner.
• Monitor and interpret new and changing regulations, guidelines, and industry standards to ensure ongoing compliance.
• Provide strategic advice to cross-functional teams (e.g., R&D, Quality Assurance, Quality Control, and Manufacturing) on regulatory requirements throughout the product lifecycle.
• Lifecycle Management:
• Manage and track the lifecycle of API registrations, including renewals, variations, and annual reports.
• Prepare and submit documentation for changes in the manufacturing process, raw materials, or specifications.
• Ensure all post-approval commitments are met.
• Documentation and Record-Keeping:
• Maintain a robust documentation management system for all regulatory submissions, approvals, and correspondence.
• Ensure all regulatory files are organized and easily retrievable for inspections and audits.
• Review and approve product-related documentation, such as labels, packaging inserts, and promotional materials, for regulatory compliance.
• Audits and Inspections:
• Facilitate and support regulatory inspections and audits by acting as a company representative.
• Prepare necessary documentation and information for inspectors.
• Assist in the development and implementation of corrective and preventive actions (CAPAs) in response to audit findings.

Interested candidate share CV to hr@ompharmaceutical.com

Job Types: Full-time, Permanent

Pay: ₹400,000.00 per year

Benefits:

• Health insurance
• Leave encashment
• Provident Fund

Work Location: In person