Regulatory Affairs Specialist

Francis Remedies (I) Pvt. Ltd.; Dadri; On-site; INR 600,000 - 900,000; Full time

Job summary

Francis Remedies (India) Pvt. Ltd. invites a Regulatory Affairs Specialist for an on-site role in Roorkee, Uttarakhand.

You will prepare, review, and maintain regulatory documentation for national and export submissions, coordinating with manufacturing, QA, R&D and marketing to ensure compliance across the product lifecycle. The position emphasizes audits, regulatory queries, and updating internal SOPs as regulations evolve.

Qualifications

• Graduate/PG in Pharmacy, Pharmaceutical Sciences, Chemistry or related field.
• 2–2.5 years of regulatory affairs experience.
• Good documentation, analytical, communication and coordination skills.

Responsibilities

• Preparation, compilation, review, and submission of regulatory dossiers.
• Working knowledge of CTD, eCTD, and ACTD dossier formats.
• Knowledge of US FDA, EU BE, PICS and other international requirements.

Skills

CTD/eCTD/ACTD

Global regulatory knowledge

Regulatory submissions

Regulatory audits

QA/QC documentation

Dossier review

Submission tracking

Cross-functional coordination

Education

Pharmacy/Pharmaceutical Sciences/Chemistry (Graduate/PG)

Job description

Company Description

Francis Remedies (I) Pvt. Ltd. is an ISO-accredited, WHO-GMP certified pharmaceutical manufacturing company based in Uttarakhand, India. The company serves domestic markets with a broad generic product line in Uttar Pradesh and handles export orders for partners in countries such as Nigeria, Colombia, and Afghanistan, as well as third-party manufacturing contracts. With a portfolio of over 250 products across multiple therapeutic categories, Francis Remedies operates advanced facilities for tablets, capsules, injectables, ointments, dry syrups, and dry injections. Promoted by a team of young entrepreneurs, the company is committed to delivering high-quality, cost-effective medications supported by robust service in registration, packaging, logistics, and delivery. Ongoing research and development focuses on innovative pharmaceutical solutions and long-term customer partnerships.

Role Description

The Regulatory Affairs Specialist is a full-time, on-site role based in Roorkee Uttrakhand. The specialist will prepare, review, and maintain regulatory documentation for national and international submissions, ensuring accuracy, completeness, and alignment with applicable guidelines. Day-to-day responsibilities include monitoring regulatory requirements, coordinating regulatory submissions for new and existing products, and supporting product registration and approvals in domestic and export markets. The role involves collaborating with manufacturing, quality assurance, research and development, and marketing teams to ensure regulatory compliance across product lifecycle. The specialist will also support audits, respond to regulatory queries, and help update internal processes and standard operating procedures in line with evolving regulations.

Company:

Francis Remedies (India) Pvt. Ltd.

Salary :

Depends Interview

Key Responsibilities & Skills:

• Preparation, compilation, review, and submission of regulatory dossiers.


• Working knowledge of CTD, eCTD, and ACTD dossier formats.


• Knowledge of USFDA, EU, BE, PICS, etc and other international regulatory requirements, guidelines, and compliance documentation


• Experience in global regulatory submissions and country-specific regulatory requirements.


• Knowledge of regulatory audits, audit preparation, and handling audit observations.


• Understanding of QA/QC documentation and pharmaceutical quality systems.


• Review of API and finished product data, including chemical study reports.


• Data synchronization, gap analysis, and dossier deficiency assessment.


• Coordination and follow-up for pre-submission, submission, and post-submission activities.


• Knowledge of regulatory documentation, compliance requirements, and submission tracking.

Candidate Requirements:

• Graduate/Postgraduate in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.


• 2-2.5 years of relevant experience in Regulatory Affairs.


• Good documentation, analytical, communication, and coordination skills.

Join Francis Remedies and grow your career in global pharmaceutical regulatory affairs!

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