AGM / Sr. Manager – Liaisoning

Utkarsh Placement Pvt. Ltd.; Vadodara; On-site; INR 3,000,000 - 3,500,000; Full time

Job summary

Utkarsh Placement Pvt. Ltd. in Vadodara invites an experienced Regulatory Affairs and Government Liaisoning professional for a senior role in an API pharmaceutical manufacturer.

The candidate will handle regulatory licensing, approvals, and government liaisoning for Oncology and Narcotic / Controlled Substances, coordinating with CDSCO, State FDA, and other authorities to secure licenses and permissions. A science postgrad with 10+ years of regulatory expertise is preferred; direct government

Qualifications

• Minimum 10 years of pharmaceutical regulatory affairs experience.
• Experience with Oncology and Narcotic / Controlled Substance approvals.
• Strong knowledge of CDSCO and State FDA licensing processes.

Responsibilities

• Handle government liaisoning and regulatory affairs for regulated pharma products.
• Coordinate with CDSCO, State FDA and other authorities.
• Obtain manufacturing licences, product approvals, and statutory clearances.
• Manage regulatory requirements under applicable acts and rules.
• Resolve queries and approvals challenges with authorities.
• Follow up to ensure timely sanctions and permissions.
• Identify regulatory needs for new product introductions and portfolio.
• Coordinate with internal departments for compliance and smooth commercialization.

Skills

Regulatory affairs

Government liaisoning

CDSCO

Oncology

Drug licensing

Education

Science graduate/PG

Job description

AGM / Sr. Manager – Regulatory Affairs & Government Liaisoning

Location: Vadodara, Gujarat
Industry: API Pharmaceuticals
CTC: ₹30–35 LPA
Qualification: Science Graduate / Postgraduate

We are hiring an experienced Regulatory Affairs and Government Liaisoning professional for a reputed API pharmaceutical manufacturing organization.

The candidate must have strong hands-on experience in regulatory licensing, statutory approvals and government liaisoning for Oncology and Narcotic / Controlled Substances.

Key Responsibilities:

• Handle government liaisoning and regulatory affairs for highly regulated pharmaceutical products.


• Coordinate with CDSCO, State FDA and other government authorities.


• Obtain manufacturing licences, product approvals, special permissions and statutory clearances.


• Manage regulatory requirements under the Drugs and Cosmetics Act, NDPS Act and applicable rules.


• Resolve regulatory queries, objections and approval-related challenges.


• Follow up with authorities to ensure timely sanctions and permissions.


• Identify regulatory requirements for new product introductions and existing portfolios.


• Coordinate with internal departments to ensure compliance and smooth commercialization.

Key Requirements:

• Science Graduate / Postgraduate with more than 10 years of experience in pharmaceutical regulatory affairs and government liaisoning.


• Mandatory experience with Oncology and Narcotic / Controlled Substance regulatory approvals.


• Strong working knowledge of CDSCO, State FDA, licensing and applicable regulatory frameworks.


• Proven experience handling government authorities and securing approvals.

Important:

Preference will be given to candidates with direct government liaisoning and approval experience rather than documentation-focused Regulatory Affairs profiles.