Associate Director Global Regulatory Affairs Development

This is what you will do :

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 :

• 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 :

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

Date Posted

04-Mar-2024

Closing Date

29-Jun-2024