Manager - Regulatory Affairs

Ascent Meditech; Bhayandar Wada; On-site; INR 1,800,000 - 2,700,000; Full time

Job summary

Ascent Meditech Limited in India seeks a Senior Manager - Regulatory Affairs to lead regulatory documentation, labeling compliance, and export verifications across multiple markets. You will coordinate with manufacturing, packaging, and quality teams to ensure registrations, certifications, and attestations are completed accurately and on time.

The role requires deep knowledge of international regulatory requirements, strong project management, and meticulous attention to detail to support

Qualifications

• In-depth knowledge of international regulatory requirements and export processes.
• Ability to coordinate with manufacturing, QA, and authorities.
• Experience preparing regulatory dossiers and submissions.
• Strong attention to detail and organizational skills.

Responsibilities

• Coordinate regulatory documentation for product registrations and re-registration in multiple countries.
• Coordinate artwork and labeling compliance with packaging teams.
• Manage legalization and attestation for documents with embassies/consulates.
• Prepare packing instructions for export orders and resolve shipping queries.
• Develop regulatory dossiers and respond to authorities or importers.
• Maintain regulatory database and ensure audit readiness.
• Coordinate with agencies for certifications and inspections.
• Obtain quotations for regulatory services and manage approvals.
• Support pre-inspection documentation and on-time shipment clearance.

Skills

Regulatory knowledge

Documentation proficiency

Export processes

MS Office proficiency

Tools

MS Office

Job description

Job Title- Senior Manager - Regulatory Affairs

Job Purpose:

The Regulatory & Export Documentation Executive will manage and coordinate all

regulatory, documentation, and compliance-related activities necessary for product

registration, export, and certification across multiple international markets. The role ensures

that all documentation, approvals, and certifications meet country-specific legal, regulatory,

and customer requirements while maintaining accuracy, timelines, and compliance

standards.

Key Responsibilities:

1. Regulatory Documentation Coordination:

• Liaise with the manufacturing unit to collect and verify all necessary

documents required for product registration, re-registration, and compliance

processes in various countries.

• Respond promptly to queries from regulatory authorities, importers, and

internal stakeholders regarding registration documentation.

2. Artwork and Labeling Compliance:

• Coordinate with the Artwork/Packaging team to develop and update product

artwork, labeling, and packaging materials in line with country-specific

regulatory requirements.

• Ensure all artwork approvals are obtained prior to production or export.

3. Legalization and Attestation Management:

• Coordinate with legalization agencies for document legalization through

embassies, consulates, and chambers of commerce as required for product

registration and export purposes.

• Ensure timely attestation and compliance with international documentation

standards.

4. Export Coordination & Packing Instructions:

• Prepare and communicate packing instructions to the manufacturing unit for

export orders.

• Address and resolve queries related to packing, shipping, and export

compliance.

5. Dossier Preparation & Submission:

• Prepare comprehensive regulatory dossiers for product registration and reregistration

in exporting countries, adhering strictly to respective country

guidelines.

• Manage follow-ups and respond to queries from regulatory authorities or

importers during the review process.

6. Barcode & Product Code Management:

• Generate and manage GS1 barcodes for all products and maintain a

centralized product code database.

• Ensure consistency and traceability of product codes across all regulatory and

export documentation.

7.

Certification & Inspection Coordination:

• Coordinate with external agencies, consultants, and importers to obtain certifications such as CE Certification and other regulatory approvals.
• Facilitate plant inspections or audits as per country-specific requirements.

8.

Regulatory Database Management:

• Maintain an up-to-date regulatory and compliance database with all registration, certification, and export-related documents.
• Ensure data accuracy and readiness for internal and external audits.

9.

Quotation & Approval Processes:

• Coordinate with agencies to obtain quotations for regulatory services and manage the internal approval process for engagements.
• Ensure timely follow-up and cost-effective vendor management.

10.

Pre-Inspection Documentation Support:

• Arrange and submit all necessary documents to inspection agencies for pre-shipment inspections.
• Ensure completeness and compliance to prevent delays in shipment clearance.

Skills & Competencies:

Strong knowledge of international regulatory requirements, documentation, and export processes.

Excellent coordination, communication, and organizational skills.

Attention to detail with the ability to handle multiple tasks and meet deadlines.

Proficiency in MS Office and regulatory database management.

Ability to liaise effectively with internal teams, external agencies, and authorities.Role & responsibilities

Email:- [e-mail]