24 Sep
|
a square remedies
|
Ahmedabad
24 Sep
a square remedies
Ahmedabad
Role Description:
The Regulatory Affairs Associate is a full-time, on-site role based in Ahmedabad.
- The associate will prepare, review, and maintain regulatory documentation required for product registrations and approvals in domestic and international markets.
- Responsibilities include coordinating regulatory submissions, tracking application status, and ensuring compliance with country-specific regulatory requirements across target regions.
- The role involves collaborating with cross-functional teams such as quality assurance, manufacturing, and marketing to gather data, support audits, and address regulatory queries.
- The associate will also monitor changes in pharmaceutical regulations, assist in updating internal processes, and help maintain accurate records and databases to support ongoing and new product launches.
Qualifications
- Candidates should possess strong skills in Regulatory Documentation and the preparation, review, and maintenance of technical dossiers.
- Candidates should possess expertise in Regulatory Compliance and understanding of applicable pharmaceutical laws, guidelines, and quality standards.
- Candidates should possess knowledge of diverse Regulatory Requirements across multiple global markets and highly regulated regions.
- Candidates should possess experience in Regulatory Submissions, including compilation, filing, and life-cycle management of product registrations.
- Candidates should possess a solid foundation in Regulatory Affairs,
with the ability to liaise with authorities and interpret regulatory updates.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Strong attention to detail, analytical thinking, and organizational skills.
- Effective written and verbal communication skills in English; proficiency in additional languages is an advantage.
- Ability to work collaboratively with cross-functional teams and meet deadlines in a fast-paced environment.
- Prior experience in pharmaceutical regulatory affairs, especially in oncology or critical care products, is preferred.
Company Description A Square Remedies Pvt. Ltd. is a dynamic pharmaceutical company that specializes in supporting multinational companies in entering highly regulated markets with strategic precision. With headquarters in Ahmedabad, Hong Kong, and Moscow, the company operates across the CIS region and several global markets, including the USA, Europe, Nepal, and the Philippines, with plans to expand into LATAM, wider Asia, and Africa.
The organization focuses on human health, with robust portfolios in oncology, cardiac/diabetic care, critical care, skincare, and wellness, covering a broad range of dosage forms such as specialty injectables, tablets, capsules, ointments, and oral liquids. Backed by more than 100 product registrations worldwide and a pipeline of over 1,500 products, A Square Remedies is recognized for its regulatory expertise, global vision, and strong execution that accelerates market access for leading pharmaceutical brands.
📌 Regulatory Affairs Associate (Ahmedabad)
🏢 a square remedies
📍 Ahmedabad