Job Description

Manager -Regulatory Affairs

• NEW PRODUCT REGISTRATION
• Supports and ensures submission of new drug approvals for assigned therapeutic area in India and for all products in neighboring countries, in line with local regulatory requirements and business plans in a timely manner.
• Coordination with HQ for dossier and compiling for new drugs assigned
• Filing new drug applications to DCGI and State FDA and their life cycle management
• Query response to DCGI
• Liaison with DCGI and state FDA for approval of new drugs assigned
• Filing and DCGI / state FDA approval of test licenses, site registration, import license and manufacturing license.

• MAINTANENCE OF EXISTING PRODUCTS -
• Ensures timely submission and follow up of both labelling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders: Ex., worldwide product labelling, CMC, RAI, HQ and regional regulatory support team.
• Manages renewal process in liaison with CMC, RAI, HQ and regional regulatory support team ensuring that renewal files are prepared, submitted and approved in due time.
• Efficient regulatory input for packaging and label components to ensure timely implementation of artwork efforts.
• Lifecycle maintenance of assigned products in India and neighboring that includes post approval changes, labelling and renewal activity
• All activities pertaining to filing/ licenses/ liaison with state FDA assigned from time to time.

• REGULATORY COMPLIANCE
• Responsible for implementing local regulatory procedures in a timely manner, in close synergy with HQ / regional groups.
• Responsible for maintaining the compliance metrics for assigned products. The compliance metrics includes Artwork compliance, E2E Labelling compliance, Database/systems.
• SPOC for archiving tool
• Meeting requirements of all regulatory compliance tools and metrics

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us--and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 25%

Flexible Work Arrangements: Hybrid

Shift: 1st - Day

Valid Driving License: Yes

Hazardous Material(s):

Number of Openings: 1