Job Description

Job Role:

New product proposal, data generation as per the USFDA guidelines for diverse dosage form eg. Injectable/ Ophthalmic/ Semi-solid etc.

Compile and review the Quality Overall Summary, Module 1 to Module 5 of all planned submissions.

Get the high-quality dossiers prepared, compiled and submit in accordance with the regulatory requirements to obtain new registration &/or post approval supplement in the international market like US, Canada etc.

Coordination with various Contract Research Organizations (CRO'S) including BE centers for data generation in chemistry, Packaging and Toxicity. Checking of protocols and study plans for conducting the studies.

Preparing draft to defend queries raised by the regulatory bodies against any molecule/ product etc.

Regulatory support to cross functional team including R&D and quality for the development and life cycle management of the products.

Partner with the different functions including R and D, Sales and Supply Chain to communicate regulatory requirements/ information to support business needs.

To update the team about recent changes in registration guidelines.

Prepare and submit due diligence reports of proposed dossiers to Senior Management.

Interact with regulatory agencies and/or trade associations within defined area(s) of responsibility/expertise.

Monitor regulatory changes, threats and opportunities to evaluate implications towards new and existing registrations.

Ensure compliance with applicable regulations including audits.

Responsible for maintaining proper records, creating and manage electronic files of labels and registration certificates.

To work closely with the international consultants to ensure timely registration.

Hands on experience in MS office (Word, Excel, PowerPoint).

Qualification :

MPHARM with 5-7 years of experience in Regulatory

Other requirements :

Good in English Communication

Able to communicate with team in USA

Hybrid working

2-8 pm from office and 9-11 pm from home .

Job Types: Full-time, Permanent

Pay: ?2,400,000.00 - ?4,000,000.00 per year

Schedule:

• Fixed shift

Supplemental Pay:

• Performance bonus

Experience:

• total: 1 year (Required)