Job Description

(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIM

Job Responsibility:

? Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA/MAA)

? Coordinate with cross functional teams (QA, QC, R&D, Manufacturing, Packaging) for

accurate documentation.

? Submit applications to US FDA, EMA, and other authorities in compliance with regional

requirements.

? Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or

equivalent.

? Ensure completeness and technical accuracy of eCTD sequences.

? Troubleshoot validation issues before final submission.

? Prepare and manage post app roval changes (CMC variations, labeling updates,

packaging changes).

? Submit supplements, amendments, and variations in accordance with regulatory

guidelines (FDA's PAS, EMA's Type IA/IB/II).

? Collaborate with internal departments to gather data and draft sc ientifically sound

responses.

? Stay updated with changes in FDA, EMA, and ICH guidelines.

? Maintain regulatory databases, submission trackers, and approval records.

? Participate in audits and support regulatory inspections.

Required Qualification & Skills :

? Bachelor's / Master's degree in Pharmacy or related field.

? 3 10 years of relevant experience in Regulatory Affairs for regulated markets ( Health

Canada/ US/EU)

? In depth knowledge of US FDA, EMA, and ICH regulatory frameworks.

? Strong understanding of dossier structure, eCTD publishing, and submission timelines.

Experience:

5 to 10 years

Location:

Ahmedabad, Gujarat (On site)

Job Types: Full-time, Permanent

Pay: ?50,000.00 - ?80,000.00 per month

Benefits:

Paid sick time Paid time off
Schedule:

Day shift Fixed shift
Application Question(s):

How many years of Health Canada experience do you have Are you comfortable with onsite working
Location:

Gota, Ahmedabad, Gujarat (Required)
Work Location: In person