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66 AstraZeneca Jobs

International CMC RA Director

10-14 years

Bangalore / Bengaluru

1 vacancy

International CMC RA Director

AstraZeneca

posted 4d ago

Job Description

Job Title: International CMC RA Director
Career Level - F
Introduction to Role:
Join us as an International CMC RA Director, where you will provide strategic, operational, and tactical expertise for projects and complex product ranges from development phase through to global launch and post-approval lifecycle management. This role is a unique opportunity to contribute to the creation of international CMC strategy, identifying risks and mitigations, and preparing for international markets based on the needs identified by the international business, markets, and patients.
Accountabilities:
As an International CMC RA Director, you will provide CMC RA expertise across the business functions, lead key business improvement initiatives, and provide operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product. You will also be accountable for managing high-level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
Essential Skills/Experience:
  • Degree /PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
  • Breadth of knowledge of manufacturing, project, technical and regulatory project management.
  • Strong understanding of regulatory affairs globally
  • Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products
  • Stakeholder & Project management
  • Professional capabilities: Regulatory knowledge
  • Post graduate qualification
  • Business, financial and supply chain understanding/ awareness
  • Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
  • Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
At AstraZenecas Biopharmaceuticals R&D division, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for whats next.
Join us and be supported to progress and develop fast. We are working towards our aspiration to make AstraZeneca the place to build a career in Regulatory. Here we inspire and support to help drive your professional and personal growth and development. With a defined career ladder, a recognition culture that celebrates successes and exciting opportunities for those with the drive to achieve.
Ready to make a difference? Apply now!
Date Posted
12-Dec-2024
Closing Date
04-Jan-2025
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Employment Type: Full Time, Permanent

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Intern salary at AstraZeneca

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13% more than the average Intern Salary in India
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What AstraZeneca employees are saying about work life

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75%
65%
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98%
Flexible timing
Monday to Friday
No travel
Day Shift
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AstraZeneca Benefits

Health Insurance
Free Transport
Free Food
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Work From Home +6 more
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