Senior Executive/Asst Manager - RA Labeling / CMC (US Market, Sterile)

About the Company

Cronus Pharma is a privately owned, rapidly expanding pharmaceutical business based in New Jersey. The company focuses on delivering innovative, cost-effective animal health solutions and began its pharma specialties initiative in India in May 2017. Its portfolio includes general injectables, solid oral dosage forms, and cephalosporin injectable products for veterinary use.

The manufacturing setup covers a broad range of general and cephalosporin specialty products, including tablets and boluses, liquid injection vials with aseptic fill and terminal sterilization, liquid-fill cephalosporin vials, lyophilized vials, and prefilled syringes.

Role Overview

This role supports US-market regulatory labeling and CMC activities for sterile products. The position involves managing labeling deliverables, coordinating submissions, maintaining documentation, and ensuring artworks and related regulatory records are ready in line with application timelines and commercial launch plans.

Key Responsibilities

• Assist with the on-time preparation, review, and filing of labeling submissions to the US FDA/CVM through the submitter.
• Collect and coordinate the information needed to complete labeling-related work.
• Support the creation, review, and approval of artworks for JINADs, NADAs, and ANADAs.
• Help prepare, review, approve, and update SPLs and drug listings before product shipment to the USA for products marketed under Cronus and private distributor labeler codes tied to Cronus-owned applications.
• Work with internal functions and CMOs to complete labeling tasks smoothly.
• Provide regular progress and status updates on labeling activities to the department head or supervisor.
• Maintain regulatory and labeling records in the appropriate systems and drives.
• Assist in preparing and filing regulatory reports, including antimicrobial reports and DERs.
• Support drug establishment registration submissions.
• Help draft and revise SOPs connected to regulatory and labeling operations.
• Track application goal dates and approval dates, and ensure artworks are prepared in time for commercial launch.

Candidate Profile

The ideal candidate should have strong working knowledge of US regulatory affairs for injectable or ophthalmic formulations. The role calls for solid communication skills and experience handling regulatory and labeling activities in a sterile product environment.

Eligibility

Applicants should hold a B.Pharm, M.Pharm, or M.Sc. degree and have 8 to 12 years of relevant experience.

Additional Information

Location: Hyderabad/Secunderabad, India.

This role is focused on the US market and sterile products.

Employment type and pay details were not specified in the source.