Acme Lifetech LLP Hiring for Regulatory Affairs Officer to Executive

Acme Lifetech LLP, a leading manufacturer of pharmaceutical formulations, is looking for talented individuals to join their Regulatory Affairs team. hiring for positions ranging from Officer to Executive in Ahmedabad. If you have an M.Pharm in Regulatory Affairs and at least one year of experience, this is your chance to advance your career with a reputable company.

Key Responsibilities

As a Regulatory Affairs Officer to Executive at Acme Lifetech LLP, your responsibilities will include:

• Regulatory Compliant Dossier Compilation: Prepare and compile dossiers in compliance with regulatory requirements for ROW (Rest of World) markets.
• Documentation Management: Maintain and organize all regulatory documents, ensuring they are up-to-date and easily accessible.
• Licensing & Legal Application: Handle licensing applications and ensure compliance with legal regulations.
• Cross-Functional Collaboration: Work closely with other departments to ensure regulatory requirements are met.
• Labeling & Artworks Development: Develop and review labeling and artwork to ensure they meet regulatory standards.
• Sample Management: Manage samples for regulatory submissions and quality checks.
• Product Lifecycle Management: Oversee the regulatory aspects of product development and lifecycle management.

Required Skillset

To be successful in this role, you should possess:

• Strong Understanding of Regulatory Affairs: A strong understanding of regulatory affairs principles, guidelines, and processes of ROW MarketCompare and evaluate offers from suppliers
• Familiarity with the applicable regulations and requirements in the specific industry or country Track orders and ensure timely delivery
• Thorough Knowledge & Experience in CTD & ACTD DossierEnter order details (e.g. vendors, quantities, prices) into internal databases
• Skilled in review of Manufacturing/Analytical /Quality/API DMF DocumentsRecord of Payment Done.
• Additionally, analytical thinking, and excellent organizational and communication skills are highly valued.

Qualifications

• Education: M.Pharm in Regulatory Affairs
• Experience: Minimum of 1 year in Regulatory Affairs

Location and Application Details

• Location: Ahmedabad

Apply Now

Apply now by sending your resume to career@acmegrp.in with the subject line “Regulatory Affairs Officer to Executive Application.”