Associate Director Global Regulatory Affairs Development

Hiring By - Biostaffic

 BioPharma

France

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Associate Director
Global Regulatory Affairs Development
Location:
Paris, FR
Job Profile:
Director, Development Strategy, US Lead
Reports To:
Executive Director, Regulatory Affairs Development Strategy, Neurology and Ophthalmology
Date:
February 2024
This is what you will do:
[Definition: Position Summary]
The Associate Director, Global Regulatory Affairs Development Strategy (GRA-DS) will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
[Definition: Job Duties and Responsibilities]
  • Serve as regulatory strategy lead within EU/designated region(s) on assigned program. May serve as global regulatory team leader on assigned programs.
  • Develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas.
  • Provide advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
  • Prepare and execute region-specific aspects of regulatory affairs and ensure integration into global regulatory strategy.
  • Represent Alexion as point of contact with regulatory authorities, including providing support for and coordination of regulatory meetings and information package development.
  • Coordinate submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc.
  • Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
  • Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
You will need to have:
[Definition: Essential Qualifications. The minimum skills and requirements needed for the position]
Qualifications
  • Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
  • Experience providing strategic regulatory advice for the global and/or EU development of products through all stages of development including pre-approval and marketed compounds.
  • Experience in leading Health Authority Interactions
  • Ability to manage complex issues and coordinate multiple projects simultaneously
  • Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.
  • Strong interpersonal, and written/verbal communication skills.
  • Proven track record practicing sound judgment as it relates to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
Education
  • Bachelor’s Degree in a related discipline
  • 7 years in pharmaceutical industry regulatory affairs
Competences
  • Ensure Accountability
  • Collaborate
  • Cultivate Innovation
  • Bei Resilient
  • Learning and Self-Development

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.

Current Openings: 0

Our mission is to transform the lives of people living with rare diseases and devastating conditions through the development and delivery of innovative medicines, as well as through supportive technologies and healthcare services. By continuing to deepen our understanding of rare disease, which began with our pioneering work in complement biology, we are able to innovate and evolve into new areas where there is great unmet need and opportunity to help patients and families fully live their best lives. Our culture is rooted in integrity, inclusiveness, and our dedication to joining and supporting the communities in which we live and work. We invest in and value people who believe in the importance of our purpose and understand what it takes to deliver on it. Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world. At Alexion, our passion drives us to continuously innovate and create meaningful value in all we do. In doing so, we change lives for the better – ours, people living with rare diseases, and the communities we serve. Every day. Community Guidelines: https://bit.ly/39x9gqy
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