ProductLife Regulatory Affairs Officer Hiring

Regulatory Affairs Officer Hiring | Remote Opportunity | Pharma Regulatory Jobs

The pharmaceutical industry continues to create strong demand for experienced Regulatory Affairs professionals who can manage product registrations, regulatory submissions, lifecycle management activities, and interactions with health authorities. A remote opportunity is currently available for Regulatory Affairs professionals with expertise in European pharmaceutical regulations and regulatory compliance.

This position is ideal for candidates seeking to advance their careers in regulatory affairs, dossier preparation, marketing authorization applications, and pharmaceutical compliance within a global regulatory environment.

Company Overview

The hiring organization provides regulatory affairs support and compliance services for pharmaceutical products across international markets. The team works closely with clients, sponsors, affiliates, and regulatory authorities to ensure timely product approvals and ongoing regulatory compliance.

Professionals joining this team will gain exposure to various regulatory activities involving medicinal product registrations, post-approval submissions, labeling reviews, and lifecycle management projects.

Job Role & Responsibilities

Regulatory Affairs Activities

• Contribute to regulatory activities performed by the Regulatory Affairs platform and hub.
• Support pre-licensing and post-licensing regulatory activities.
• Assist with new registrations for medicinal products and manufacturing sites.
• Participate in regulatory submissions and approval processes.
• Support interactions with health authorities on behalf of clients.

Regulatory Documentation

• Prepare administrative documents required for regulatory submissions.
• Compile regulatory dossiers according to country-specific requirements.
• Support preparation and review of Module 1 documentation for pre-approval and post-approval applications.
• Maintain submission-ready regulatory documentation.

Regulatory Compliance & Tracking

• Document and track regulatory submissions and approvals.
• Maintain regulatory databases and tracking systems.
• Ensure regulatory activities comply with applicable pharmaceutical regulations.
• Support regulatory reporting and performance metrics.

Lifecycle Management Activities

Support regulatory activities related to:

• Initial Marketing Authorization Applications (MAA)
• Minor Variations
• Major Variations
• Renewals
• Sunset Clause Activities
• Labelling Changes
• Article 61.3 Procedures
• Marketing Authorization Transfers
• Manufacturing Changes
• Post-Approval Regulatory Maintenance

Cross-Functional Support

• Provide regulatory support to clients and associated companies.
• Coordinate with sponsor head offices and affiliate departments.
• Liaise with external regulatory authorities when required.
• Review packaging texts and labeling documents.
• Review Summary of Product Characteristics (SmPC).
• Review Patient Information Leaflets (PIL).
• Mentor and support Regulatory Affairs Associates.
• Assist Regulatory Affairs Specialists and project teams on regulatory initiatives.

Eligibility / Qualifications

Educational Qualification

Candidates should possess a Bachelor’s degree or higher qualification in a science-related discipline.

Relevant educational backgrounds include:

B.Pharm, M.Pharm, Pharm D, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmaceutical Sciences, Clinical Research, Regulatory Affairs, Pharmaceutical Technology, Biomedical Sciences, Chemistry, MSc Chemistry, Healthcare Sciences, Life Sciences, and other related scientific disciplines.

Experience Required

• 4 to 6 years of Regulatory Affairs experience.
• Experience in European pharmaceutical regulations.
• Experience handling regulatory submissions and approvals.
• Knowledge of lifecycle management activities and post-approval changes.
• Experience preparing Module 1 regulatory documentation.

Language Requirements

• Strong written English communication skills.
• Good verbal communication skills.
• Additional language proficiency will be an advantage.

Technical Skills

• Regulatory Tracking Systems
• Regulatory Affairs Databases
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Electronic Document Management Systems

Preferred Skills

• Excellent organizational skills
• Strong attention to detail
• Effective communication abilities
• Team collaboration skills
• Process-oriented approach
• Ability to manage multiple regulatory projects

Location & Salary

Location: Remote (India)

Salary: ₹8 LPA – ₹14 LPA (Approximate Industry Standard)

Application Process

Interested candidates can apply through the link below:

Application Link: https://www.linkedin.com/jobs/view/4423391478/

Frequently Asked Questions (FAQs)

1. What qualification is required for this Regulatory Affairs Officer position?

Candidates should possess a Bachelor’s degree or higher qualification in Pharmacy, Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related scientific disciplines.

2. Is prior Regulatory Affairs experience mandatory?

Yes. Applicants should have 4–6 years of experience in Regulatory Affairs, preferably with exposure to European regulations.

3. Is this a remote job opportunity?

Yes. This is a full-time remote position.

4. What regulatory activities will the selected candidate handle?

The role involves dossier preparation, regulatory submissions, lifecycle management activities, labeling reviews, health authority interactions, and regulatory compliance support.

5. What is the expected salary range?

The approximate market salary for professionals with similar experience ranges between ₹8 LPA and ₹14 LPA.

6. Is experience with European regulations required?

Yes. Experience in European pharmaceutical regulatory affairs is one of the key requirements for this role.

---

Job Summary

Category	Details
Company	Pharmaceutical Regulatory Services Organization
Department Vacancies	Regulatory Affairs Officer
Qualification	Bachelor’s Degree or Higher in Science, Pharmacy, Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field
Experience	4–6 Years
Location	Remote (India)