Merck KGaA

Specialist - Regulatory Affairs Manager

Posted On

Oct. 7, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

The Specialist, Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel Who You Are:Experience: 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 Education: Degree in a Life Science or a related discipline, preferably MSc Job Specific Competencies & SkillsExperience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variationsExperience 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 globallyUnderstanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization frameworkAbility to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per requestAdherence to agreed timelines and proactive communication of any potential risk to the sameProject management and documentation skills, proactive communication approachContributor level of experience with RIM, Vault and EDMS RA applicationsExcellent written and spoken English language Job Location:Electronic City Phase 1 - Bangalore -We have several openings for License Management roles for various levels and profiles.-Expectations and scope of responsibilities provided in this Job posting are for Specialist level.-The exact designation to be offered will depend on applicants’ experience and knowledge confirmed during the screening process. We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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