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Amgen Inc
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Regulatory Affairs Manager

Regulatory Affairs Manager

Amgen Inc

5 - 8 years

7 - 10 Lacs

hyderabad

Posted:1 month ago| Platform:

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Skills Required

regulatory submissions regulatory regulatory affairs clinical trials product registration ectd pharmaceutical usfda documentation anda dossier dossier preparation drug ra ich ctd clinical development drug regulatory affairs dmf actd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role Name: Manager International Regulatory Lead (IRL)
Department Name: International Regulatory Team, Global Regulatory AffairsRole GCF: 5A

ABOUT THE ROLE

Role Description

Roles & Responsibilities

Basic Qualifications and Experience
Doctorate degree ORMaster's degree and 3 years of relevant regional regulatory experience ORBachelor's degree and 5 years of relevant regional regulatory experience ORAssociate degree and 10 years of relevant regional regulatory experience ORHigh school diploma/GED and 12 years of relevant regional regulatory experience.

Functional Skills

Must-Have Skills

Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.

Good-to-Have Skills

Soft Skills

Strong communication skills, both oral and written
Ability to understand and communicate scientific/clinical information
Ability to work effectively with global, local and virtual teams
High degree of initiative and self-motivation
Planning and organizing abilities
Ability to manage multiple priorities successfully
Team-oriented, with a focus on achieving team goals
Good negotiation and influencing skills.

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Amgen Inc

Biotechnology

Thousand Oaks

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Regulatory Affairs Manager