Lexine Technochem Pvt. Ltd. is a WHO, ISO 9001:2008, and GMP Certified pharmaceutical company based in Vadodara, Gujarat. Specializing in the production of herbal and pharmaceutical formulations, the company is known for its diverse product range, which includes liquids, ointments, tablets, capsules, powders, and injectables. Lexine Technochem is dedicated to preventive and curative solutions, offering wellness products that meet high regulatory and safety standards.
Job Responsibilities: As a Regulatory Affairs professional at Lexine Technochem, you will be responsible for:
- Managing regulatory documentation in compliance with pharmaceutical industry standards.
- Preparing and submitting regulatory dossiers to various authorities.
- Ensuring the company’s products comply with national and international regulatory frameworks.
- Coordinating with other departments to gather necessary information for regulatory submissions.
- Staying updated on changing regulatory guidelines and requirements to maintain compliance.
This on-site, full-time role requires attention to detail and the ability to manage multiple regulatory tasks efficiently.
Qualifications: To be eligible for this role, candidates must possess:
- A Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related field.
- In-depth knowledge of regulatory documentation, compliance, and submission processes.
- A solid understanding of pharmaceutical regulatory frameworks.
- Excellent organizational skills and attention to detail.
- The ability to work well in a team and communicate effectively across departments.
Skills Required:
- Expertise in Regulatory Documentation, Regulatory Compliance, and Regulatory Submissions.
- Strong understanding of global and local Regulatory Requirements.
- High level of attention to detail and ability to handle large volumes of documentation.
- Ability to work effectively within a team environment and collaborate with other teams.
