Lupin Hiring For Regulatory Affairs Department in Mumbai, Maharashtra

We Are Hiring For Officer - Regulatory Affairs in Airoli Mumbai, Maharashtra

Lupin Hiring For Regulatory Affairs Department in Mumbai, Maharashtra

Job Description

Join Lupin, a leading pharmaceutical company, as a Regulatory Affairs Officer in our Airoli facility. This role is ideal for a highly motivated individual with 1-2 years of experience in regulatory affairs for regulated markets, specifically focusing on USFDA submissions. You will play a crucial role in managing the lifecycle of pharmaceutical products destined for the US market.

Required Qualifications & Experience

We are looking for a candidate who meets the following criteria:

Work Experience: 1 to 2 years of proven experience in Regulatory Affairs within a regulated market environment (e.g., US, EU, etc.).

Education: M.Sc, Graduation in Pharmacy (B.Pharm)

Location: 

Key Responsibilities

• As a Regulatory Affairs Officer, your primary focus will be on ensuring timely and compliant submissions to US regulatory authorities, including the USFDA.
• Lead and manage regulatory submissions for a diverse portfolio of products, including Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market.
• Ensure timely and compliant responses to product deficiency letters raised by US regulatory authorities.
• Manage all post-approval submissions and annual reports for USFDA-approved products, ensuring continuous lifecycle management and compliance.
• Drive labeling updates in strict alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA.
• Provide essential regulatory support for PADER (Periodic Adverse Drug Experience Reports), contributing to the company’s global pharmacovigilance and safety monitoring efforts.
• Review and provide strategic regulatory input on documentation throughout the entire product development, scale-up, and commercial manufacturing stages.
• Oversee documentation reviews for externally manufactured products, ensuring robust regulatory consistency and quality standards across all partnerships.

Essential Competencies

Lupin values the following core competencies in its team members:

Customer Centricity

Collaboration & Stakeholder Management

Strategic Agility & Process Excellence

Innovation & Creativity

Developing Talent & Result Orientation

How to Apply

1.Click here For Apply

2.Register using your email ID and create a login.

3.Fill in your personal and educational details accurately.

4.Upload your updated resume in PDF format.

5. Submit it.