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CMC Regulatory Affairs Associate Director

  • Job
    Full-time
    Senior & Expert Level
  • Consulting
    Science
  • Quick Apply

AI generated summary

  • You need a science degree, CMC regulatory experience with biologics, and knowledge of global regulations, especially for antibody drug conjugates, radioconjugates, or bispecifics.
  • You will devise regulatory strategies for biological entities, lead interactions with health authorities, ensure CMC compliance, mentor colleagues, and support process improvements and due diligence.

Requirements

  • Bachelor’s degree 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, particularly with respect to the CMC field
  • Regulatory Affairs CMC experience with submissions for biologics drug substances and products.
  • Advanced degree in a science or technical field such as pharmacy, biology, chemistry, or biological science
  • Regulatory Affairs CMC experience with submissions for antibody drug conjugates, radioconjugates or bispecifics

Responsibilities

  • Use your regulatory experience to devise creative strategies to support a range of new biological entities and novel products, from development to post approval lifecycle management.
  • Provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, based on understanding of global CMC regulations.
  • Handle high level risk by making sophisticated judgments, developing innovative solutions, and applying comprehensive cross-functional and industry understanding.
  • Have a high level of interactive social skills and cultural sensitivity which you will use to advise CMC teams on how to achieve successful regulatory outcomes.
  • Lead project driven regulatory interactions with health authorities, e.g. FDA, EMA, for CMC scientific advice.
  • Lead and/or deliver CMC Regulatory components of business process improvement projects.
  • Ensure the application of global CMC regulations and guidance within AstraZeneca and lead development of new guidance.
  • Share your knowledge actively within CMC RA and the wider business, participate in the coaching and mentoring of colleagues and keep up to date with emerging global regulatory requirements.
  • You may also be asked to support due diligence reviews.

FAQs

Where is the job location for the CMC Regulatory Affairs Associate Director position?

The job is located in Barcelona, Spain, with a hybrid work model requiring three days in the office and two days working from home.

What is the focus area for the CMC Regulatory Affairs Associate Director role?

The focus area includes support for the biologics technical area, encompassing both traditional and novel molecules.

What are the primary responsibilities of the CMC Regulatory Affairs Associate Director?

Responsibilities include devising regulatory strategies for biological entities, providing expertise to project teams, leading regulatory interactions with health authorities, and sharing knowledge within the CMC department.

What qualifications are required for this position?

A Bachelor’s degree in a science or technical field, knowledge of manufacturing and regulatory project management, a strong understanding of global regulatory affairs, and CMC experience with submissions for biologics drug substances and products are required.

Are there any preferred qualifications for the role?

Yes, an advanced degree in a science or technical field and CMC experience with submissions for antibody drug conjugates, radioconjugates, or bispecifics are preferred.

How does the CMC Regulatory Affairs Associate Director collaborate with other teams?

This role collaborates with cross-functional Regulatory Strategy, Pharmaceutical and Global Supply Teams, and works with colleagues in marketing companies globally to ensure successful regulatory outcomes.

What level of experience is necessary for the CMC Regulatory Affairs Associate Director?

Candidates should have significant experience in regulatory affairs, particularly in the CMC field, with a proven track record of handling complex regulatory submissions.

Will the CMC Regulatory Affairs Associate Director be involved in coaching or mentoring?

Yes, the Associate Director is expected to actively share knowledge and participate in the coaching and mentoring of colleagues within the CMC Regulatory Affairs team.

What types of regulatory interactions will the Associate Director lead?

The Associate Director will lead project-driven regulatory interactions with health authorities such as the FDA and EMA, especially for CMC scientific advice.

Is there an emphasis on keeping up to date with regulatory changes?

Yes, staying updated with emerging global regulatory requirements is a crucial part of the role.

What science can do

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. AstraZeneca is a global pharmaceutical company dedicated to improving the health and well-being of people worldwide. With a focus on innovative research and development, AstraZeneca develops and manufactures a wide range of prescription medicines, including treatments for cardiovascular, respiratory, oncology, and other therapeutic areas. Their aim is to transform the lives of patients by discovering, developing, and delivering innovative medicines that address unmet medical needs. AstraZeneca's purpose is to push the boundaries of science and collaborate with healthcare professionals, organisations, and communities to improve patient outcomes and contribute to the advancement of healthcare globally.