Associate Director Global Regulatory Affairs Development

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

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.