Regulatory Affairs- Executive – (Injectables)

Cadila Pharmaceuticals Limited is inviting applications for the position of Executive – Regulatory Affairs (Injectables).

Experienced regulatory professionals with expertise in injectable pharmaceutical products and regulatory submissions for the United States (USFDA) market can apply.

If you have a passion for regulatory compliance, dossier preparation, and cross-functional collaboration, this opportunity offers an excellent platform to grow your career with one of India's leading pharmaceutical companies.

Position: Executive – Regulatory Affairs (Injectables)

Department: Regulatory Affairs

Location: Dholka, Gujarat, India

Experience Required: Minimum 4 Years

Regulatory Market: USA (USFDA)

Product Segment: Injectable Dosage Forms Only

As an Executive – Regulatory Affairs, you will be responsible for managing regulatory activities related to injectable pharmaceutical products intended for the US market.

Your responsibilities include:

1. Regulatory Dossier Preparation

Compile, review, and submit registration dossiers for injectable dosage forms.

Ensure dossiers comply with USFDA regulatory requirements.

2. Regulatory Query Management

Handle regulatory deficiencies, queries, and information requests received from regulatory authorities.

3. Supplements & Variations

Prepare and submit regulatory supplements and variations for injectable products.

Ensure regulatory submissions remain compliant with changing guidelines.

4. Documentation Review

Review and evaluate critical regulatory documents including:

Product specifications

Test procedures

Product Development Reports (PDR)

Stability protocols and reports

Process validation protocols and reports

Media filter validation documents

Sterility assurance documents

Change Control documentation

Deviation reports

5. Regulatory Compliance

Maintain up-to-date knowledge of current regulatory guidelines issued by:

USFDA/ICH/European regulatory authorities (where applicable).

Ensure submissions meet current regulatory expectations.

6. Regulatory Database Management

Create, update, and maintain regulatory databases.

Track submission status, approvals, deficiencies, and lifecycle management activities.

7. Cross-Functional Coordination

Collaborate with internal departments to ensure timely preparation and submission of regulatory documents.

Monitor timelines for regulatory filings and agency responses.

8. Stakeholder Collaboration

Work closely with:

Research & Development (R&D)

Quality Assurance (QA)

Quality Control (QC)

Manufacturing

Supply Chain

to facilitate timely submissions, regulatory approvals, and effective query resolution.

Interested candidates meeting the above criteria are encouraged to apply by sending their updated resume to:

Email: ayushi.rana@cadilapharma.com