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## Job Title

Senior Regulatory Affairs Officer

Department: Regulatory Affairs

## Purpose of the Role The Senior Regulatory Affairs Officer is responsible for supporting regulatory operations by managing submissions, maintaining regulatory databases, ensuring compliance with applicable regulations, and coordinating with internal teams and regulatory authorities. The role ensures timely execution of regulatory activities while maintaining high standards of documentation, accuracy, and confidentiality.

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# Key Responsibilities

## 1. DCGI Regulatory Submissions

- Maintain and upload regulatory data on Health Authority portals (SUGAM, FDA, and FSSAI).
- Prepare and submit application dossiers, including:
- New Drug Applications
- Renewals
- Post-approval maintenance submissions
- Other regulatory applications
- Maintain regulatory tracking sheets, including:
- Product submission trackers
- Marketing Authorizations
- License conditions
- PSUR tracking
- Site registrations
- Import licenses
- Reference standards
- Test import licenses
- CMC and safety variations
- Maintain accurate electronic and physical records for all submissions to ensure easy retrieval.

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## 2. State FDA Regulatory Activities

Manage preparation and submission of applications related to:

- Loan License renewals and maintenance
- Wholesale License renewals and maintenance
- Recent Wholesale License applications
- Additional manufacturing facility approvals
- Product permission renewals
- New product permission applications
- COPP applications
- WHO GMP inclusion applications
- WHO GMP and COPP renewals for manufacturing facilities

### Institutional Certificates

Coordinate preparation and renewal of certificates such as:

- Non-Conviction Certificate
- State GMP Certificate
- GLP Certificate




- Manufacturing & Marketing Certificate
- Performance Certificate
- Production Certificate
- Proprietary Certificate
- Other certificates as required by regulatory authorities

Additional responsibilities include

- Coordinating with State FDA officials
- Maintaining FDA regulatory trackers
- Ensuring complete documentation and filing of submissions

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## 3. Global Regulatory Databases

- Maintain and update global and local regulatory databases.
- Ensure registration databases remain accurate and compliant with applicable regulatory requirements.

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## 4. Clinical & Bioequivalence (BE) Studies

- Submit clinical study applications through SUGAM.
- Coordinate sample procurement and labeling.
- Track CRO milestone payments.
- Coordinate purchase orders, invoicing, and payment follow-up with Finance.
- Maintain CRO databases.
- Ensure proper filing and documentation of all clinical study records.

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## 5. FSSAI Activities

- Upload data and regulatory fees for various FSSAI applications through the online portal.

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## 6. Packaging Material Regulatory Validation

Act as the regulatory representative for packaging material validation by:

- Ensuring packaging creation or modification requests comply with applicable regulations.
- Defining regulatory implementation timelines for packaging changes.
- Reviewing packaging mock-ups for regulatory compliance.




- Verifying printing proofs (BAT) against approved regulatory documentation and current legislation.

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# General Responsibilities

- Perform additional regulatory activities as assigned by management.
- Complete all administrative tasks associated with the Regulatory Affairs function.
- Maintain strict confidentiality of company and regulatory information.
- Build effective working relationships with cross-functional teams.
- Ensure compliance with company policies, procedures, and regulatory standards.

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# Candidate Profile

## Education

- Bachelor's degree in Science, Pharmacy, Life Sciences, or a related discipline.

## Experience

- Experience in Regulatory Affairs or regulatory operations within the pharmaceutical industry.
- Familiarity with regulatory submission processes and documentation.

## Technical Knowledge

- Knowledge of pharmaceutical regulatory requirements.
- Experience with regulatory portals such as SUGAM and FSSAI.
- Proficiency in Microsoft Office (Excel, PowerPoint, Word).
- Experience maintaining regulatory databases and submission trackers.

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# Required Skills & Competencies

- Knowledge of pharmaceutical regulatory requirements
- Strong documentation and record management skills
- Regulatory submission and compliance experience
- Excellent organizational and prioritization skills
- Strong written and verbal communication
- Attention to detail and accuracy
- Ability to work independently with minimal supervision
- Adaptability and flexibility
- Scientific aptitude and analytical thinking
- Ability to learn quickly and manage multiple priorities
- Cross-functional coordination and stakeholder management
- Professionalism, integrity, and confidentiality

📌 Sr. Regulatory Affairs Officer (Mumbai)
🏢 Servier Pharmaceuticals
📍 Mumbai