Job Description:
Position: RA Trainee(Khopoli)
Location: Khopoli - Raigarh
Experience: 0 -1 Years
Industries: Pharma
Responsibilities:
- Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets.
- Support the collection and review of technical documents from R&D QA QC and Production departments.
- Help maintain regulatory databases tracking sheets and product registration status logs.
- Learn and follow current regulatory guidelines (USFDA WHO MHRA EU CDSCO).
- Assist in the submission of post-approval changes annual updates and renewal applications.
- Draft and format regulatory documents letters and summaries.
- Help respond to regulatory agency queries and deficiencies under guidance.
- Ensure compliance with documentation practices data integrity and version control systems.
Required Skills
- Basic knowledge of GMP ICH and regulatory guidelines
- Understanding of dossier structure (Modules 15) is a plus
- Good written and verbal communication skills
- Attention to detail and strong organizational skills
- Ability to work in a team and meet deadlines
- Proficiency in MS Office (Word Excel Outlook)
Required Qualification:- :- Upto 2.10 LPA
If you are interested for this opening please send updated resume on or revert on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
Required Experience:
Intern
Job Description:Position: RA Trainee(Khopoli)Location: Khopoli - RaigarhExperience: 0 -1 YearsIndustries: PharmaResponsibilities:Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets.Support the collection and review ...
Job Description:
Position: RA Trainee(Khopoli)
Location: Khopoli - Raigarh
Experience: 0 -1 Years
Industries: Pharma
Responsibilities:
- Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets.
- Support the collection and review of technical documents from R&D QA QC and Production departments.
- Help maintain regulatory databases tracking sheets and product registration status logs.
- Learn and follow current regulatory guidelines (USFDA WHO MHRA EU CDSCO).
- Assist in the submission of post-approval changes annual updates and renewal applications.
- Draft and format regulatory documents letters and summaries.
- Help respond to regulatory agency queries and deficiencies under guidance.
- Ensure compliance with documentation practices data integrity and version control systems.
Required Skills
- Basic knowledge of GMP ICH and regulatory guidelines
- Understanding of dossier structure (Modules 15) is a plus
- Good written and verbal communication skills
- Attention to detail and strong organizational skills
- Ability to work in a team and meet deadlines
- Proficiency in MS Office (Word Excel Outlook)
Required Qualification:- :- Upto 2.10 LPA
If you are interested for this opening please send updated resume on or revert on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
Required Experience:
Intern
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