Manager Regulatory Coordination & Government Affairs

Experience: 57 years

Industry: Pharmaceutical / Healthcare

Function: Government Affairs, Regulatory Compliance & Statutory Coordination

Reporting To: Senior Management / Director

Role Purpose The Manager Government Affairs & Regulatory Compliance will be responsible for managing the company's interactions with government departments, regulatory authorities, statutory bodies and other relevant institutions.

The role will serve as the central point of coordination for obtaining and maintaining government approvals, licences, registrations, certificates, permissions and other statutory requirements applicable to the company's business.

The position will also be responsible for monitoring changes in applicable laws, regulations, notifications, circulars and government procedures, assessing their impact on the organisation.

Key Responsibilities

1. Government Affairs & External Coordination

- Manage the company's day-to-day interactions with government authorities on matters relating to licences, approvals, registrations, permissions and statutory requirements.
- Coordinate with government officials regarding applications, submissions, approvals, inspections, clarifications and other official matters.
- Follow up with relevant authorities and ensure that pending matters are progressed and closed within the required timelines.
- Coordinate meetings and discussions with government departments and officials as required.
- Represent the company before government authorities where duly authorised.
- Understand government processes and procedures and identify the appropriate channels for progressing company matters.
- Maintain proper records of government communications, submissions, approvals and other official correspondence.

1. Licence, Registration & Permission Management

- Develop and maintain a comprehensive Licence & Regulatory Compliance Record covering all applicable licences, registrations, certificates, approvals and permissions.

- Maintain details including

- Licence / registration name

- Issuing authority

- Licence / registration number

- Date of issue

- Expiry date

- Renewal requirements

- Applicable department

- Responsible person

- Current status
- Monitor expiry dates and initiate renewal processes sufficiently in advance.
- Coordinate with concerned departments, consultants and authorities for timely renewal and modification of licences and registrations.
- Ensure that changes in company structure, business activities, premises, products or personnel are appropriately reflected in applicable registrations and permissions.
- Identify any missing or additional approvals required as the company's business activities expand.

1. Regulatory & • Legal Monitoring





- Continuously monitor amendments to applicable laws, regulations, rules, government notifications, circulars, guidelines and procedures.
- Track regulatory developments relevant to the company's pharmaceutical, commercial, employment, tax, corporate, operational and other activities, as applicable.
- Maintain a Regulatory Amendment & • Update Tracker

.
- Identify changes that may impact the company's operations, licences, processes or obligations.
- Coordinate with Legal, Regulatory Affairs and external advisors where specialist interpretation is required.

1. Implementation of New Regulatory Requirements

- Assess the practical impact of new or amended laws and regulations on the company's operations.
- Identify the departments, processes, licences or activities affected by regulatory changes.

- Coordinate with concerned departments to ensure that required changes are implemented.

1. Compliance Calendar & • Monitoring

- Develop and maintain a central Government & • Regulatory Compliance Calendar

.
- Track all recurring and one-time statutory, regulatory and government requirements.
- Ensure timely initiation and completion of applications, renewals, filings, submissions and other regulatory activities.
- Coordinate with internal teams and external consultants wherever required.
- Conduct periodic reviews of upcoming compliance requirements.

1. Government Inspections, Notices & • Queries

- Coordinate with relevant departments in preparation for government inspections, audits and regulatory visits.
- Coordinate responses to government notices, queries, requests for information and official communications.

- Ensure that responses are prepared and submitted within prescribed timelines.
- Maintain records of inspection reports, observations, notices and responses.
- Track corrective actions arising from inspections and ensure timely closure.

- Escalate significant observations or regulatory risks to senior management.

1. Cross-Functional Coordination

- Ensure that relevant government requirements and regulatory developments are communicated to the appropriate teams.

- Coordinate matters where government approvals or permissions require inputs from multiple departments.
- Track dependencies and ensure that concerned teams complete their respective actions.
- Support departments in understanding and implementing applicable government requirements.

Key Deliverables / KPIs




- Timely renewal of all applicable licences, registrations and permissions.
- No avoidable expiry or lapse of critical licences and approvals.
- Accuracy and completeness of the Licence & Regulatory Compliance Register.

- Timely identification and communication of relevant regulatory amendments.
- Timely implementation of applicable changes in laws and regulations.
- Timely closure of government queries, notices and inspection observations.

- Effective tracking and closure of government-related matters.
- Timely completion of statutory and regulatory requirements.
- Reduction in delays in obtaining government approvals and permissions.

- Regular and accurate reporting of government and regulatory matters to management.

Candidate Profile

Experience

- 57 years of relevant experience in Government Affairs, Regulatory Compliance, Corporate Affairs, Statutory Compliance or a similar role.

- Experience in the pharmaceutical / healthcare industry is strongly preferred.
- Prior experience dealing directly with government departments, regulatory authorities and statutory bodies is essential.
- Experience managing multiple licences, registrations and government approvals would be an advantage.

- Experience across multiple countries or jurisdictions would be an added advantage.

Required Skills
- Excellent communication and stakeholder-management skills.
- Strong follow-up and execution capabilities.

- Ability to understand and interpret regulatory notifications and amendments.
- Robust organisational and documentation skills.
- Ability to manage multiple government and compliance matters simultaneously.

- Strong analytical and problem-solving abilities.
- Excellent attention to detail and deadline management.
- Ability to work independently and proactively identify upcoming requirements.

- Ability to communicate regulatory requirements clearly to non-legal and non-regulatory teams.

Ideal Candidate The ideal candidate will be a proactive, execution-oriented Government Affairs and Compliance professional who can independently manage the company's government-related requirements from initiation through completion.

The person should be capable of answering, at any point in time:

What approvals and licences do we need? When do they expire? What renewals or permissions are pending? What has changed in the law? Does the change apply to us? What action is required? Who is responsible for implementing it? Has it actually been implemented?

The role is therefore intended to function as a central control point for Government Affairs and Regulatory Compliance, ensuring that the company remains up to date with government requirements and that applicable regulatory changes are effectively implemented across the organisation.

📌 Manager Regulatory Coordination and Government Affairs (Delhi)
🏢 Protech Biosystems
📍 Delhi