Regulatory Affairs

Position: Asst. Manager

Qualification: M.Pharm /B.Pharm/M.Sc. having 8+ years experience in EU/ LATAM market

Job profile:

1. Responsible for the designated regulatory projects with respective deadlines

2. Expertise in authoring CMC documentation for EU MAA and post-approval submissions with hands-on experience on using eCTD software

1. Good coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines
2. Review the documents against the Agency guidances assuring regulatory compliance
3. Keep knowledge up to date about regulatory guidelines

6. Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)

Position: Sr.Officer/ Executive

Qualification : M.Pharm /B.Pharm/M.Sc. having 4-6 years experience in US market

Job profile:

1) Author and compile CMC documentation for ANDA filings and post-approval submissions

2) Coordination with stakeholders on regular basis to source the documents in accordance with project timelines

3) Review the documents against the FDA guidances assuring regulatory compliance

4) Keep knowledge up to date with regard to regulatory guidelines

5) Hands-on experience on using eCTD software

Position: Officer

Qualification : M.Pharm /B.Pharm/M.Sc. having 2-3 years experience in US market

Job profile:

1) Author and compile CMC documentation for ANDA filings and post-approval submissions

2) Coordination with stakeholders on regular basis to source the documents in accordance with project timelines

3) Review the documents against the FDA guidances assuring regulatory compliance

4) Keep knowledge up to date with regard to regulatory guidelines

5) Hands-on experience on using eCTD software

Position: Asst. Manager/ Sr.Exexcutive

Qualification : M.Pharm /B.Pharm/M.Sc. having 8+ years experience in US market

Job profile:

1) Responsible for the designated regulatory projects with respective deadlines

2) Expertise in authoring CMC documentation for ANDA filings and all post-approval submissions

3) Good coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines

4) Review the documents against the FDA guidances assuring regulatory compliance

5) Keep knowledge up to date with regard to regulatory guidelines

6) Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)