Dear Candidate,
Greeting from USV Pharmaceuticals Pvt Ltd
Position: Sr. Officer / Executive
Location: Govandi East ( Mumbai )
Alternate Saturday working (2nd & 4th Saturday Off)
Market : USA
Dosage Form : Solid Orals
Position Summary
We are seeking a Sr. Officer/ Executive – Regulatory affairs (USA) to join our team, he will be reporting to
Sr. Assistant General Manager in this role, you will be responsible for Dossier compilation, preparation,
Life cycle management, Pre approval, Post approvals.
Key Responsibilities:
Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products
to get licenses from various targeted markets.
Prepare the checklist for documentation for regulatory filings as per current regulatory
requirements (country specific).
Collate and conduct first-level review/overview of relevant standard technical documentation like
stability, TTD, PDR, method validations etc. as per the country requirements.
Conduct initial review of the specifications of the API / Semi-Finished Product / Finished Product
as per the regulatory requirements.
Conduct initial review of labelling/artwork as per the market where the dossier is being filed
Review and regulatory impact analysis of the change control, communication with customer for
notification and approval as applicable.
Review and regulatory impact analysis of the changes notified by the vendors as per current
regulatory requirements (country specific), as desired.
Evaluate any changes proposed post-approval. Prepare and file necessary amendments /
supplements / annual reports as applicable to ensure regulatory compliance (Post-approval Life
Cycle Management).
e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health
Authorities.
Assist in resolution of queries received from customer/agency/regulator and assessing them
before sharing with team leader.
Preparation of Approval Package and sharing them with the respective manufacturing sites.
Prepare and e-file documents for registration of any facility used (in process for drug) with
USFDA
Proficiencies and Expertise
Masters degree/ Bachelor degree in Science Proven experience in Regulatory affairs with 1-4 year of handling solid oral dosage form for US market would be preferred
Interested candidates are requested to send their updated resume to the following email id: [email protected]
