Associate Director Global Regulatory Affairs
hace 7 días
Location:
Barcelona, Spain
Job reference:
R-193794
Date posted: 03/04/2024
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 regionspecific 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.
- 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 preapproval and marketed compounds.
- Experience in leading Health Authority Interactions
- Ability to manage complex issues and coordinate multiple projects simultaneously
- Ability to build intrateam 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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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