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.

**Job Types**: Full-time, Permanent

Pay: ₹400,000.00 per year

**Benefits**:

- Health insurance
- Leave encashment
- Provident Fund

Work Location: In person