Specialist - Regulatory Affairs

Merck Kgaa

2-3 years

Not Disclosed

Mumbai

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Specialist - Regulatory Affairs

Location: Mumbai, India

About Us:

At [Company Name], we are passionate about innovating with science and technology to enrich people’s lives. We believe in imagining the unimaginable, exploring new boundaries, and making a lasting impact on healthcare, life sciences, and electronics. Together, we aim to care for our customers, patients, and planet, fostering a diverse and inclusive work culture that enables personal development and career growth.

Your Role:

As a Regulatory Affairs Specialist, you will support India-specific regulatory activities, ensuring compliance with regulations and facilitating timely submissions for product registrations, renewals, and minor submissions across the APAC region. You will work closely with cross-functional teams to ensure all product-related activities meet regulatory and business requirements. Your role will also involve managing the regulatory systems, database maintenance, and coordination with health authorities in India.

Key Responsibilities:

Regulatory Submissions & Maintenance:
- Assist in the maintenance of product registrations and licenses in regulatory systems and databases, such as SharePoint and team folders.
- Perform labelling reviews and assist with project creation in the Artwork Management system (WebCenter).
- Support the timely submission of product renewals, site registrations, and minor product submissions to relevant health authorities in APAC countries.
- Ensure the update of the Veeva Vault related to Life Cycle Management (LCM) activities, including Marketing Authorization renewals and site registrations.
Cross-Functional Communication:
- Ensure effective communication across regulatory affairs teams, both top-down and bottom-up.
- Provide support for cross-functional activities and collaborate with other teams as required.
Regulatory Intelligence & Reporting:
- Conduct timely regulatory intelligence searches for relevant countries and update the Country Regulatory Tool system.
- Generate regional reports, process vendor payments, and manage country-specific requests.
Support Regional/Global Initiatives:
- Participate in regional, global, or local hub initiatives to support regulatory affairs strategies.
- Contribute to the review and improvement of hub processes to achieve greater efficiency.
Submission & Dossier Management:
- Align with country-specific submission strategies for site registrations.
- Assist in maintaining registrations and licenses of products in regulatory systems.
- Ensure timely submission of dossiers and Veeva Vault updates related to site registration and other submissions.
Miscellaneous Activities:
- Provide support for other regulatory and cross-functional activities as necessary.
- Request sample collections via the K2 system and manage vendor payments.

Who You Are:

Education:
- Bachelor’s or Master’s degree in Pharmacy or a related field (D.Pharma also acceptable).
Experience:
- 2-3 years of experience in the Indian Regulatory Market.
- Familiarity with regulatory bodies such as CDSCO, Import and State FDA.
Skills:
- Fluent in written and spoken English.
- Knowledge of regulatory requirements and procedures for product registrations and licensing in India.
- Experience with regulatory tools, databases (such as Veeva Vault), and systems used in regulatory affairs.
Personal Attributes:
- Strong attention to detail and the ability to manage multiple tasks effectively.
- Excellent communication skills, both verbal and written.
- Ability to work independently as well as part of a collaborative team.

What We Offer:

At [Company Name], we believe diversity drives excellence and innovation. We are committed to creating an inclusive and supportive environment where everyone can grow and develop at their own pace. With access to various career opportunities and a flexible working culture, we empower individuals to reach their full potential and champion human progress.

Apply Now and Become a Part of Our Diverse Team!
Join us in contributing to innovation that impacts millions of lives worldwide.

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