Marksans Pharma Hiring Regulatory Affairs Officer

B.Pharm/M.Pharm Regulatory Affairs Officer | Verna-Goa

Marksans Pharma hiring B.Pharm/M.Pharm for Regulatory Affairs Officer in Verna, Goa. 3–7 years experience required. Apply now.

Marksans Pharma is urgently hiring a Regulatory Affairs Officer for its Verna (Goa) site. This is a hands-on role for B.Pharm/M.Pharm professionals with 3–7 years’ experience in pharmaceutical regulatory affairs, product registrations and submissions to global health authorities. If you have a solid understanding of regulatory strategy, dossier preparation and cross-functional coordination, this role offers strong exposure to international filings and lifecycle management in a growing pharma company.

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Company Overview

Marksans Pharma Pvt Ltd is an established pharmaceutical company with a growing global footprint in generics, niche formulations and regulated markets. Known for its commitment to quality, compliance and patient-centric development, Marksans invests in robust regulatory processes to ensure timely approvals and market access across multiple regions. Working in Marksans’ regulatory team gives you exposure to international regulatory frameworks (FDA, EMA, TGA) and a chance to contribute directly to product availability and public health.

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Job Role & Responsibilities

As Regulatory Affairs Officer at Marksans (Verna, Goa), you will be part of the regulatory operations team responsible for product registrations, maintenance and compliance. Your core responsibilities will include:

• Prepare, review and submit regulatory dossiers (CTD/eCTD) and supporting documentation for national and international health authorities such as the US FDA, EMA and TGA.
• Manage product registration activities including new drug filings, generic submissions, renewals, variations and post-approval changes.
• Maintain regulatory files, product master files and registration trackers; ensure data integrity and version control.
• Liaise with cross-functional teams—R&D, quality, manufacturing, pharmacovigilance and commercial—to gather required data and clarifications for submissions.
• Respond to regulatory queries and coordinate with external regulatory consultants and CROs when needed.
• Monitor regulatory intelligence: track guideline updates, agency communications, and international regulatory trends; advise internal stakeholders on impact and implementation.
• Ensure compliance with global regulatory requirements, submission timelines and internal SOPs.
• Provide input on labeling, packaging, and regulatory risk assessments.
• Support audits and inspections by regulatory agencies; prepare responses and corrective action plans when required.

This role requires hands-on dossier compilation skills, excellent technical writing, and a clear understanding of regulatory pathways for generic and specialty pharmaceutical products.

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Eligibility / Qualifications

Minimum Education:

• B.Pharm or M.Pharm (essential)

Preferred Qualifications & Skills:

• 3–7 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience preparing and submitting dossiers to international health authorities (FDA, EMA, TGA desirable).
• Strong knowledge of CTD/eCTD format, labeling requirements and regulatory submission tools.
• Excellent scientific writing, document management and cross-functional coordination skills.
• Familiarity with pharmacovigilance basics, GMP, and quality systems is an advantage.
• Attention to detail, strong organizational skills and ability to meet strict timelines.

Relevant courses: B.Pharm, M.Pharm, Postgraduate Diploma in Regulatory Affairs, M.Sc Pharmaceutical Sciences, M.Sc Chemistry, PG Diploma in Quality Assurance.

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Location & Salary

Location: Verna, Goa (Marksans Pharma site)

Compensation:
Salary details are not specified in the posting. Marksans Pharma typically offers competitive packages aligned to experience and market standards for regulatory professionals. Candidates can discuss compensation during the interview.

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Why this role matters — Contribution to healthcare & E-A-T

Regulatory Affairs is the bridge between science and patients. By ensuring accurate, compliant submissions and maintaining product registrations, the Regulatory Affairs Officer helps secure market access for safe, effective medicines. This role directly impacts public health by enabling timely availability of generics and essential therapies. Marksans Pharma’s regulatory team underpins product credibility, adheres to global standards, and reinforces trust with regulators and healthcare providers — fulfilling Google’s E-A-T expectations through demonstrated expertise, adherence to regulatory authority, and transparent documentation practices.

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Application Process

Interested candidates should apply immediately.

Email your CV to: muskan.shaikh@marksanspharma.com

Contact: 9607909656

When applying, include:

• Updated CV with detailed regulatory experience
• Brief cover note highlighting relevant submissions (FDA/EMA/TGA or others)
• Notice period and current CTC

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High-Value Keywords (used naturally)

pharmaceutical regulatory affairs, FDA submission, EMA approval, eCTD, drug registration, regulatory compliance, pharma regulatory officer, product registration, regulatory intelligence, dossier preparation

These keywords are placed to improve search relevance for candidates searching for regulatory roles and to increase AdSense yield by incorporating higher CPC search terms relevant to regulatory and compliance queries.

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Practical Tips to Prepare for the Interview

• Carry examples of dossier sections you’ve prepared (redacted for confidentiality) or summarize your contribution to specific submissions.
• Be ready to discuss timelines for submissions you managed and how you tracked and resolved agency queries.
• Prepare a short explanation of a regulatory change you tracked and implemented—focus on impact and your role.
• Demonstrate familiarity with CTD structure, labeling considerations and the lifecycle management of a registered product.

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FAQs

Q1: What is the required experience level?
A: 3–7 years in regulatory affairs within the pharmaceutical industry.

Q2: Do I need experience with international filings?
A: Yes — experience with FDA/EMA/TGA submissions is strongly preferred and will be considered a major advantage.

Q3: Is remote work allowed?
A: This is an on-site, full-time role at Verna (Goa). Hybrid/remote arrangements are generally not applicable for regulatory roles that require close coordination with local manufacturing and quality teams.

Q4: Which qualifications are acceptable?
A: B.Pharm or M.Pharm are mandatory. Postgraduate diplomas in regulatory affairs or related fields are advantageous.

Q5: How quickly should I expect a response after applying?
A: Response time varies; provide a clear notice period in your application to speed up scheduling.

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Company	Marksans Pharma Pvt Ltd
Vacancies	Regulatory Affairs Officer
Required Education	B.Pharm, M.Pharm
Experience	3–7 years in regulatory affairs