Senador Laboratories Hiring Regulatory Affairs Officer

Senador Laboratories Pvt Ltd; Vapi; On-site; INR 600,000 - 900,000; Full time

Job summary

Senador Laboratories Pvt. Ltd, part of Insud Pharma, invites applications for a Regulatory Affairs Officer (B.Pharm/M.Pharm) with 1–4 years in regulatory submissions for the domestic market. The role covers lifecycle management, documentation review, and cross-functional coordination to ensure compliance.

Location is Sarigam, near Vapi, Gujarat. Candidates should possess B.Pharm or M.Pharm and strong regulatory knowledge. The company emphasizes quality, audits, and regulatory excellence.

Qualifications

• Educational Qualification: B.Pharm or M.Pharm from a recognized institution.
• Experience Required: 1–4 years in the pharmaceutical industry, preferably in regulatory affairs.
• Expertise in regulatory submissions, product re-qualification, and site transfer projects.
• Knowledge of technical documentation, BMR/BPR, stability protocols, and change control processes.
• Understanding of regulatory audits, domestic market compliance, and FDA regulations.
• Strong communication, coordination, and analytical skills.

Responsibilities

• Regulatory Submissions: Compile, review, and share technical data for regulatory submissions of new projects, site transfers, and product re-qualification.
• Ensure timely availability of technical inputs for document clearance, including Product Recipes, Packaging Recipes, Artworks, and Specifications.
• Documentation Review & Approval: Review and approve critical documents such as BMR, BPR, Stability Protocols, Transit Trial Protocols, and Change Controls.
• Maintain compliance with regulatory audits and quality standards.
• Cross-functional Coordination: Work with R&D, QA, and Manufacturing teams to ensure data accuracy and regulatory compliance.
• Support regulatory audits and timely responses to queries from authorities.
• Regulatory Knowledge Application: Apply knowledge of FDA, domestic regulatory requirements, and international standards to submissions and documentation.

Skills

Regulatory submissions

Product re-qualification

Site transfer

BMR/BPR

Stability protocols

Change controls

Regulatory audits

Domestic compliance

Communication

Coordination

Analytical skills

Education

B.Pharm

M.Pharm

Job description

Regulatory Affairs Officer – B.Pharm/M.Pharm – Sarigam

Senador Laboratories hiring Regulatory Affairs Officer (B.Pharm/M.Pharm) with 1-4 yrs experience in pharmaceutical submissions & domestic market – Sarigam.

Join Senador Laboratories Pvt. Ltd, a global leader in female healthcare pharmaceuticals, as a Regulatory Affairs Officer. This is an exceptional opportunity for professionals with B.Pharm or M.Pharm qualifications and 1–4 years of experience to contribute to regulatory submissions, compliance, and lifecycle management of high-quality products in the domestic pharmaceutical market.

Company Overview

Senador Laboratories Pvt. Ltd is part of Insud Pharma, a global European pharmaceutical company renowned for its dedication to women’s healthcare. With advanced manufacturing facilities in Ahmedabad and Sarigam, Senador Laboratories focuses on delivering safe, effective, and innovative pharmaceutical products to women worldwide.

The company emphasizes quality assurance, regulatory compliance, and continuous improvement across all its operations, ensuring that products meet both domestic and international regulatory standards.

Job Role & Responsibilities

As a Regulatory Affairs Officer, you will play a pivotal role in ensuring smooth regulatory submissions and maintaining compliance across all stages of product lifecycle management. Your responsibilities will include:

• Regulatory Submissions:

  • Compile, review, and share technical data for regulatory submissions of new projects, site transfers, and product re-qualification.

  • Ensure timely availability of technical inputs for document clearance, including Product Recipes, Packaging Recipes, Artworks, and Specifications.

• Documentation Review & Approval:

  • Review and approve critical documents such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Stability Protocols, Transit Trial Protocols, and Change Controls.

  • Maintain compliance with regulatory audits and quality standards.

• Cross-functional Coordination:

  • Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that all technical data is accurate and compliant.

  • Support regulatory audits and facilitate timely responses to any queries raised by authorities.

• Regulatory Knowledge Application:

  • Apply knowledge of FDA, domestic regulatory requirements, and international standards to all submissions and documentation processes.

  • Stay updated with regulatory guidelines to ensure company compliance.

Eligibility / Qualifications

• Educational Qualification: B.Pharm / M.Pharm from a recognized institution.

• Experience Required: Minimum 1–4 years in the pharmaceutical industry, preferably in regulatory affairs.

• Key Skills:

  • Expertise in regulatory submissions, product re-qualification, and site transfer projects.

  • Knowledge of technical documentation, BMR/BPR, stability protocols, and change control processes.

  • Understanding of regulatory audits, domestic market compliance, and FDA regulations.

  • Strong communication, coordination, and analytical skills.

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Location & Salary

• Work Location: Sarigam, near Vapi, Gujarat, India

• Salary: Competitive, based on industry standards and experience.

Why Join Senador Laboratories?

• Global Affiliation: Part of Insud Pharma, a renowned European healthcare company.

• Career Growth: Gain experience in regulatory submissions, product re-qualification, and site transfer projects.

• Impactful Work: Contribute to women’s healthcare products reaching domestic and international markets.

• Professional Development: Work in a structured environment that emphasizes regulatory compliance, audits, and quality standards.

FAQs

Q1. What experience is needed for this role?

• 1–4 years of experience in regulatory affairs or related pharmaceutical functions.

Q2. Which educational qualifications are accepted?

• B.Pharm or M.Phrm graduates from recognized institutions.

Q3. What are the key responsibilities?

• Compilation, review, and approval of regulatory documentation, support for submissions, and coordination for product re-qualification and site transfer projects.

Q4. Is prior FDA knowledge required?

• Knowledge of FDA guidelines is preferred, along with domestic regulatory experience.

Q5. How to apply?

Summary

• Company: Senador Laboratories Pvt. Ltd (Part of Insud Pharma)
• Vacancies: Regulatory Affairs Officer (Male)
• Required Education: B.Pharm, M.Pharm, Pharmaceutical Regulatory Affairs
• Experience: 1-4 Years (Pharma industry, regulatory submissions & compliance)