Opportunity as a Regulatory Affairs Trainee at Unison Pharmaceuticals – Freshers can apply

Welcome to a remarkable career opportunity with Unison Pharmaceuticals Pvt Ltd! We are delighted to announce openings for Regulatory Affairs Trainees, offering a unique chance for aspiring professionals to embark on a rewarding journey in the pharmaceutical industry.

In this comprehensive guide, we will delve into the specifics of the Regulatory Affairs Trainee role, shedding light on the responsibilities, qualifications, and the vibrant work culture at Unison Pharmaceuticals. Whether you’re a recent graduate with a passion for regulatory affairs or an individual looking to transition into this dynamic field, this opportunity is tailored for you.

Job Title: Regulatory Affairs Trainee
Experience: Fresher to 6 months
Education: M. Pharm

Job Responsibilities:
1. Regulatory Documentation: Prepare and compile regulatory documents for submission to health authorities in ROW (Rest of the World) and EMB (Emerging Markets), ensuring compliance with regulatory requirements.
2. Submission Management: Assist in the preparation, submission, and maintenance of regulatory filings for new products, variations, and renewals.
3. Regulatory Compliance: Stay updated on regulatory guidelines and requirements for assigned markets, ensuring adherence to regulatory standards and timely implementation of changes.
4. Collaboration with Cross-Functional Teams: Work closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to gather necessary information and documentation for regulatory submissions.
5. Regulatory Strategy: Contribute to the development of regulatory strategies for product registrations, ensuring alignment with company goals and objectives.
6. Regulatory Intelligence: Monitor and analyze regulatory trends, changes, and developments in the pharmaceutical industry to provide insights and recommendations to the regulatory team.
7. Communication with Health Authorities: Facilitate communication with health authorities as needed, responding to queries and requests for additional information.
8. Quality Assurance: Ensure that regulatory documents and processes comply with quality standards and regulatory requirements.

Job Requirements:
1. Educational Qualification: M. Pharm in Regulatory Affairs or related field.
2. Communication Skills: Excellent written and verbal communication skills in English.
3. Analytical Skills: Strong analytical and problem-solving skills, with attention to detail.
4. Team Player: Ability to work effectively in a collaborative, cross-functional team environment.
5. Adaptability: Willingness to learn and adapt to evolving regulatory requirements.
6. Local Candidates Preferred: Candidates from Ahmedabad or nearby areas are preferred.
7. Computer Proficiency: Proficient in Microsoft Office Suite and familiarity with regulatory submission software/tools.

How to Apply:
Interested candidates meeting the above requirements are invited to apply by sharing their CV to the following email address: maitrivakil@unisonpharmaceuticals.com.
Please include “Application for Trainee – International Regulatory Affairs” in the subject line of the email.

Location: Vastrapur, Ahmedabad

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