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.
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Cronus Pharma Specialties Hiring for Regulatory Affairs[/caption]
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
https://pharmastuff.org.in/job/cronus-pharma-specialties-hiring-regulatory-affairs
