Experience
2 - 4 yrs
Job Location
Mumbai, India
Vacancy
1
Designation
Senior Regulatory Affairs Officer
Job Type
ONSITE
Job Description
RESPONSIBILITIES
- Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage.
- Publishing in eCTD format and submission to respective Regulatory Agencies.
- Compilation and submission of variation applications for EU and/or UK.
- Review of documents related to compilation of dossiers, variations and query responses.
- Up to date knowledge of EU regulatory guidelines and requirements.
DESIRED SKILLS
- Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle
- Should have handled initial MAA submission & Variations for EU.
- Good technical knowledge with respect to solid oral dosage forms.
- Adept at review of manufacturing and analytical documentation from a regulatory perspective.
- Strong knowledge of CTD /eCTD requirements and hands-on experience with compilation of CTD modules 1 to 5 is mandatory.
- Hands on experience with portal submissions would be preferable.
- Ability to try new approaches when faced with challenges.
- Should have good analytical and learning attitude.
- Good communication (written and oral) and inter-personal skills.
No Referrers Available
There are currently no referrers available for this job. You can still apply, will let you know once there is any referrer available.