Specialist - Regulatory Affairs Manager

Merck; Bengaluru; Presencial; INR 1.400.000 - 2.800.000; Jornada completa

Descripción de la vacante

Merck in Bengaluru, India, invites applications for a Specialist Regulatory Affairs Manager. The role focuses on preparing regulatory dossiers and managing lifecycle activities to ensure license security and product compliance across markets.

You will work in a matrix setup with extensive collaboration with stakeholders from multiple functions within Global Regulatory Affairs and beyond. A strong background in pharma regulatory affairs and cross-functional communication is essential.

Formación

• Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D related to the role.
• Minimum 1 year of Regulatory affairs experience.
• Degree in a Life Science or a related discipline, preferably MSc.
• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations.
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset).

Responsabilidades

• Prepare dossiers and execute actions that support license security and product compliance.
• Coordinate with stakeholders across various functions in a matrix organization.
• Engage in extensive communication and collaboration with Global Regulatory Affairs and other departments.

Conocimientos

Regulatory affairs

Project management

Documentation

Educación

MSc in Life Science

Life Science degree

Herramientas

RIM

EDMS RA

Descripción del empleo

Your Role

The Specialist Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authoritiesrequirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach. Will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs.

Who You Are

Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 1 year of Regulatory affairs experience. Degree in a Life Science or a related discipline, preferably MSc. Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations. Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset).

Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally. Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtOs, AFs, CLs, PoAs etc.) as well as legalization framework. Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request. Adherence to agreed timelines and proactive communication of any potential risk to the same. Project management and documentation skills, proactive communication approach. Contributor level of experience with RIM and EDMS RA applications.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.