Manager, Regulatory Affairs

Job Description

Manager, Regulatory Affairs

THE OPPORTUNITY
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

WHAT WILL YOU DO:

1. NEW PRODUCT REGISTRATION

Develops, drives and finalizes new products approvals in India and for all products in neighboring markets, in line with local regulatory requirements and business plans.

Ensures submission in a timely manner and follow up to obtain earliest approvals for new products approvals in India and for neighboring markets.

During the assessment of the registration files, ensures adequate follow-up with regulatory agencies and addresses quickly agencies’ requests on quality clinical and non-clinical information.

Coordinates actions effectively and proactively with HQ and local support groups and in order to support products launches in due time and avoid business loss.

2. MAINTANENCE OF EXISTING PRODUCTS

Ensures timely submission and follow up of both labeling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders: Ex., worldwide product labeling, CMC, RAI, HQ and

regional regulatory support team.

Ensures timely submission and follow up of quality-related variations (CMC) to the marketing authorizations, in cooperation with the key stakeholders to the Health Agency laboratory.

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.

3. REGULATORY COMPLIANCE

Responsible for implementing local regulatory procedures in a timely manner, in close synergy with HQ /regional groups.

Trains appropriate personnel on regulatory procedures.

Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures

4. REGULATORY INTELLIGENCE
 

• Pro-actively shares intelligence on competitive products, generics, as well as on emerging regulations
• Responsible for supporting competitive intelligence

WHAT YOU MUST HAVE:

Education - Bachelor degree in Biological Sciences - eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.

Working knowledge of Indian regulatory mechanism

Detail oriented, meticulous and organized
Basic IT knowledge
Able to work within targeted timelines
Good project management skills
Self-motivated and strong commitment to achieve desired results and right first time

Team player

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

Required Skills:

Accountability, Accountability, Adaptability, Biological Sciences, Biomedical Sciences, Biotechnology, Detail-Oriented, Digital Analytics, Documentations, Electronic Common Technical Document (eCTD), Employee Training Programs, Healthcare Innovation, Immunochemistry, Medical Communications, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Approvals, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting {+ 3 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.