Regulatory Affairs Officer – Regulatory Affairs | Marksans Pharma Pvt Ltd | Verna, Goa, India
Marksans Pharma Pvt Ltd is hiring a skilled Regulatory Affairs Officer for its pharmaceutical operations in Verna, Goa, India. This full-time opportunity is ideal for professionals with 3–7 years of experience in regulatory affairs within the pharmaceutical industry. The role focuses on preparing regulatory documentation, managing global submissions, and ensuring compliance with international regulatory guidelines. Marksans Pharma is a globally recognized pharmaceutical manufacturer specializing in generic formulations and healthcare products. The Regulatory Affairs Officer will work closely with quality assurance, production, and R&D teams to maintain regulatory compliance and support product registrations across multiple markets. This position provides excellent exposure to global regulatory standards and offers an opportunity to work in a fast-growing pharmaceutical manufacturing environment.
Location
Verna, Goa, India
Employment Type
Full-time
Experience Required
3–7 Years
Compensation & Benefits
Competitive pharmaceutical industry salary, professional growth opportunities, and exposure to international regulatory submissions.
About Marksans Pharma Pvt Ltd
Marksans Pharma Pvt Ltd is a leading pharmaceutical company specializing in the manufacturing and marketing of generic pharmaceutical formulations across global markets.
Position Overview
The Regulatory Affairs Officer will manage regulatory submissions, documentation, and compliance processes to support pharmaceutical product approvals.
Key Responsibilities
- Prepare and review regulatory submission dossiers for global markets.
- Compile documentation for product registrations and variations.
- Ensure compliance with regulatory authorities and international guidelines.
- Coordinate with quality assurance and production teams.
- Maintain regulatory documentation and product files.
- Monitor regulatory updates and guideline changes.
- Support audits and regulatory inspections.
- Assist in lifecycle management of pharmaceutical products.
- Review labeling and packaging compliance.
- Communicate with regulatory authorities when required.
Required Skills & Competencies
- Strong understanding of pharmaceutical regulatory guidelines.
- Experience with global regulatory submissions.
- Knowledge of CTD and eCTD documentation.
- Understanding of pharmaceutical product registration processes.
- Attention to detail in regulatory documentation.
- Ability to coordinate with cross-functional teams.
- Knowledge of GMP and regulatory compliance.
- Analytical and documentation skills.
- Ability to track regulatory updates and compliance requirements.
- Effective communication and reporting skills.
Educational Qualification
BPharm or MPharm
About the Project & Industry
The role supports regulatory compliance and product approvals within the pharmaceutical manufacturing industry serving global healthcare markets.
Why Join Marksans Pharma Pvt Ltd?
Marksans Pharma offers strong career growth, global exposure, and opportunities to work in regulatory affairs within a reputed pharmaceutical manufacturing organization.
How to Apply
Interested candidates can send their resume to muskan.shaikh@marksanspharma.com
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