Exciting Career Opportunity in Regulatory Affairs

Cohance Life Sciences is inviting applications for the position of Senior Executive – Regulatory Affairs at its Ankleshwar location. This opportunity is ideal for experienced regulatory professionals who have a strong background in API (Active Pharmaceutical Ingredient) manufacturing and global regulatory submissions.

The company is seeking candidates who can effectively manage international regulatory requirements, maintain compliance with global health authorities, and support business growth through successful regulatory strategies and submissions.

Position Details

Job Title: Senior Executive – Regulatory Affairs

Location: Ankleshwar, Gujarat, India

Company: Cohance Life Sciences

Eligibility Criteria

Minimum 6+ years of experience in a pharmaceutical API manufacturing company.

Educational qualification: Science Graduate or Postgraduate.

Strong knowledge of global regulatory requirements and submission processes.

Experience handling regulatory dossiers and health authority communications.

Key Responsibilities

1. Global Regulatory Submissions

Manage regulatory submissions for APIs across regulated markets.

Handle DMFs, CEPs, registration dossiers, amendments, renewals, and agency responses.

Coordinate submissions for the US, Europe, China, Brazil, Korea, Russia, and other global markets.

2. Regulatory Documentation Management

Prepare, review, and submit:

Drug Master Files (DMFs)

Open DMFs (ODMFs/APDMFs)

Technical packages

Customer-specific regulatory documents

Ensure all documentation complies with international regulatory standards.

3. API Lifecycle Management

Oversee the complete lifecycle of API regulatory filings.

Manage annual reports, Letters of Authorization (LOAs), commitments, variations, and deficiency responses.

Support customer regulatory queries and inspections.

4. Health Authority Communication

Coordinate responses to regulatory agencies.

Ensure timely resolution of deficiencies and compliance issues.

Maintain strong relationships with global regulatory authorities and customers.

5. Regulatory Systems & Platforms

Candidates should be familiar with various regulatory submission platforms, including:

PharmaReady

Lorenz eCTD Validator

EMA Portal

CESP

ESG Gateway

Solicita

CDER NextGen Portal

Other global health authority submission systems

Why Join Cohance Life Sciences?

Opportunity to work with global regulatory markets.

Exposure to international health authorities and submission processes.

Professional growth in a dynamic pharmaceutical environment.

Collaborative and inclusive workplace culture.

Involvement in strategic regulatory projects with global impact.

Application Process

Interested candidates can share their updated CV along with:

Current CTC details

CTC breakup

Notice period information

Email: Jsoni@cohance.com

Frequently Asked Questions (FAQs)

1. What experience is required for this Regulatory Affairs role?

Candidates should have a minimum of 6 years of experience in an API manufacturing company, with expertise in global regulatory submissions, dossier preparation, and regulatory compliance.

2. What qualifications are acceptable for this position?

Applicants must possess a Science Graduate or Postgraduate degree from a recognized institution.

3. Which international markets will the selected candidate handle?

The role covers submissions and regulatory activities for major regulated markets including the United States, Europe, China, Brazil, Korea, Russia, and other global regions.

4. What regulatory documents should candidates be familiar with?

Candidates should have experience working with DMFs, CEPs, APDMFs, ODMFs, registration dossiers, technical packages, annual reports, LOAs, amendments, and renewals.

5. What technical regulatory software and portals are used in this role?

The selected candidate is expected to work with platforms such as PharmaReady, Lorenz eCTD Validator, EMA Portal, CESP, ESG Gateway, Solicita, and CDER NextGen Portal, along with other health authority submission systems.

Conclusion

The Senior Executive – Regulatory Affairs position at Cohance Life Sciences offers a valuable opportunity for experienced regulatory professionals looking to advance their careers in the pharmaceutical API sector. Candidates with strong knowledge of global regulatory frameworks, dossier management, and international submission platforms are encouraged to apply and become part of a growing organization committed to excellence and compliance.