Cronus Pharma Specialties Hiring for Regulatory Affairs

Cronus Pharma Specialties is seeking a highly skilled Assistant Manager for Regulatory Affairs in Hyderabad. This role is ideal for professionals with 8-10 years of experience in regulatory submissions, particularly for USFDA and EU markets. Candidates with a background in M Pharmacy, MSc, B Pharmacy, or a related science field are encouraged to apply. If you have a passion for ensuring compliance and managing regulatory affairs in the pharmaceutical industry, this opportunity is for you.

Roles & Responsibilities

• Review technical documents & author dossier (Injectables) in CTD format for US (ANADA). Assessment, preparation of CMC query responses & coordination skills with CFT.
• Assessment & review of change controls (Injectable facility & CMC) and finalize the reporting category.
• Post approval life cycle management activities:
• Preparation & review of CMC supplements.
• peparation & review of Annual Reports.
• Provide guidance to R&D team during product development.
• Liaise with US Agent (US office) regarding all submission requirements and regulatory strategy.
• Co-ordinate with internal QC/QA for timely receipt of documents for dossier compilation Liaise with R&D Team for any formulation related documentation strategy.
• Mentor and coach Team with current regulatory requirements and be current with all latest guidelines affecting the product submissions.
• Maintain, evaluate, update new software or hardware requirements for submission purposes
• Required Skills, Experience & Qualification:
• Prior knowledge and experience of US regulatory submissions (main requirement) and EU submissions is desired.
• Knowledge of FDA, CGMP, ICH, DMF guidelines for regulatory submissions
• Hands on experience in labelling revisions, submissions, supplemental applications
• Excellent written and verbal communication skills
• Ability to work independently and handle a Team of four or more.
• Excellent analytical and problem-solving skills.
• Proficient with applicable database and compliance software
• Proficient with Microsoft Office Suite or similar software.

Required Skills, Experience & Qualification

• Experience: 8-10 years in Regulatory Affairs of finished dosage formulations, mainly for USFDA and EU submissions.
• Education: M Pharmacy, MSc, B Pharmacy, or a science background. Regulatory certifications like RAPS are preferable.
• Skills:
  • Knowledge of FDA, cGMP, ICH, DMF guidelines.
  • Hands-on experience with labeling revisions, submissions, and supplemental applications.
  • Excellent written and verbal communication skills.

How to Apply

Send your CV to: hre@cronuspharma.com or planthre@cronuspharma.com

For more information, contact HR at 7337445157 / 7337445197.

Interview Location

Cronus Pharma Specialties India Pvt Ltd,
Plot No: 1-98/5/78, Jubilee Enclave,
Madhapur, Hitech City, R R (D),
Hyderabad, Telangana – 500081