Merck KGaA

Specialist Regulatory CMC

Posted On

July 2, 2024

Location

Bangalore, Karnataka

Experience Level

C - Professional (1-3 years)

Job Type

full-time

Apply By

Sept. 24, 2024

Job Description

Title: Specialist – Regulatory CMCLocation: Bangalore – Electronic City Job Description:Leadership: No specific skills expected. Management and Planning: Ability to execute assigned tasks with support from team lead/mentor. Adherence to agreed timelines and proactive communication of any potential risk to the same. Provide high quality deliverables as per Company standards, “right first time”. Solid knowledge of Company systems and databases (APT, Trackers, RIMS/Veeva, EDMS). Familiar with Company´s organization and able to identify relevant contributors and stakeholders within the organization as per project. Project management and documentation skills, proactive communication approach. Ability to provide standard presentation with minimal guidance and support. Communication and Collaboration: Excellent written and spoken English language. Demonstrates proficiency in day-to-day business communication. Demonstrates proficiency in compiling and delivering presentations to a target group of people within the own area of specialization/ project environment. Consistently takes an active role in networking activities within own area of specialization/ project environment. Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes). Recognizes other’s point of view and makes sure that everyone is listened to and understood. Pursues active networking across disciplines/ areas, projects. Systems and Applications: User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint). User has contributor level of experience with RIMS and EDMS RA application. Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required. The output of the user will usually undergo standard QC/spot check procedure. Regulatory Expertise: 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, AtO’s, AFs, CLs, PoA’s 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. Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details. Ability to understand and support the life cycle management of regulatory CMC activities Experience in management of regulatory CMC documentation, including variations. Experience with regulatory CMC life-cycle management activities. Practical experience in one of the following areas for biotech or chemical molecules: manufacturing process development, transfers, validation or analytical development and quality management. Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries. Education: Degree in a Life Science or a related discipline, preferably MSc.Work Experience: 5-6 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role.Minimum 3 years of Global CMC regulatory experience.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, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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