Marksans Pharma Hiring Regulatory Affairs – Labelling

Marksans Pharma Ltd; Poriebhat; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Marksans Pharma Ltd in Verna, Goa invites B Pharm/M.Pharm professionals with 5–8 years' experience in Regulatory Affairs – Labelling. Immediate joiners preferred.

You will ensure labels comply with regulatory standards, coordinate with R&D, Production and Marketing, and maintain robust labeling documentation.

This role offers a challenging opportunity to contribute to global regulatory submissions and ensures product safety and compliance.

Qualifications

• B Pharm or M.Pharm with 5–8 years in Regulatory Affairs focusing on labeling.
• Experience with labeling compliance, reference drugs, and artwork submission.
• Immediate joiners preferred.

Responsibilities

• Ensure product labels comply with regulatory standards and company policies.
• Maintain accurate labeling documentation per national and international guidelines.
• Coordinate with R&D, Production, and Marketing for timely labeling submissions.
• Review and support commercial labeling activities to ensure compliance.

Skills

ANDA & OTC

Regulatory guidelines

Attention to detail

Cross-functional coordination

Timeline management

Education

Bachelor in Pharmacy / M.Pharm

Job description

Marksans Pharma Hiring B Pharm/M.Pharm Regulatory Affairs – Labelling in Goa

Marksans Pharma seeks B Pharm/M.Pharm candidates with 5-8 yrs experience in Regulatory Affairs – Labelling at Verna, Goa. Immediate joiners preferred.

Marksans Pharma Ltd., a leading player in the Indian pharmaceutical industry, is inviting applications for the role of Regulatory Affairs – Labelling at its Verna, Goa facility. This is an exceptional opportunity for professionals with expertise in regulatory compliance and pharmaceutical labelling to contribute to the timely and accurate management of product labelling processes.

Company Overview

Marksans Pharma Ltd. is a well-established pharmaceutical company recognized for its robust manufacturing capabilities and extensive product portfolio that spans generic and branded formulations. With a commitment to innovation, quality, and patient safety, Marksans Pharma has earned a strong reputation in both domestic and international markets.

Key Highlights:

• Established Indian pharmaceutical company with global reach.
• Expertise in ANDA (Abbreviated New Drug Application) submissions and OTC products.
• Strong focus on regulatory compliance, R&D, and quality assurance.
• Active contribution to healthcare and patient safety initiatives.

Job Role & Responsibilities

The Regulatory Affairs – Labelling position involves ensuring that all pharmaceutical product labels are compliant with regulatory standards and company policies. The key responsibilities include:

• Ensuring product labelling aligns with reference drugs and national brand requirements.
• Maintaining accurate documentation as per national and international regulatory guidelines.
• Coordinating with cross-functional teams, including R&D, Production, and Marketing, for timely submission of labelling and artwork.
• Reviewing and supporting commercial labelling activities to ensure compliance.

Skills & Competencies

• Strong understanding of ANDA, OTC Monograph, and regulatory guidelines.
• Attention to detail in reviewing labelling and artwork.
• Effective coordination and communication skills to liaise with multiple departments.
• Ability to manage timelines and ensure timely regulatory submissions.

Eligibility / Qualifications

• Qualification: B Pharm or M.Pharm.
• Experience: 5 to 8 years in Regulatory Affairs with focus on labelling.
• Preference for immediate joiners.

Relevant Courses: B Pharm, M.Pharm, Pharmaceutical Sciences, Regulatory Affairs Certification courses.

Location & Salary

• Location: Verna, Goa
• Salary: Competitive and as per industry standards (specifics to be discussed during selection).

FAQs

Q1: What is the required experience for this position?
A1: Candidates should have 5 to 8 years of experience in Regulatory Affairs, particularly in labelling.

Q2: What educational qualifications are acceptable?
A2: B Pharm or M.Pharm graduates are eligible.

Q3: Is the position based in Verna, Goa?
A3: Yes, the job location is Verna, Goa.

Q4: How can I apply for this role?

Q5: Are immediate joiners preferred?
A5: Yes, candidates who can join immediately will be given preference.

Contact Number: 7447488738