Associate Director, Global Regulatory Affairs

hace 3 semanas

Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

**Associate Director, Global Regulatory Affairs Development Strategy**

**Location**: Barcelona, ES; Mississauga, CA; Dublin, IE ; Boston, US ; Paris, FR
**Reports To**: Perrine Geoffroy, Executive Director, Global Regulatory Affairs Development Strategy

**This is what you will do**:
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.

**You will be responsible for**:

- Working with manager to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas.
- May serve as global regulatory team leader on assigned programs.
- Providing advice on regulatory issues for 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.).
- Preparing and executing region-specific aspects of regulatory affairs, and ensures integration into global regulatory strategy.
- Representing Alexion as point contact with regulatory authorities, including providing support for and coordination of regulatory meetings and information package development.
- Monitoring the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
- Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies

**You will need to have**:

- Bachelor’s Degree in a related discipline
- 7 years in pharmaceutical industry regulatory affairs
- Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
- Experience providing strategic regulatory advice for the global development of products through all stages of development.
- 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
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

**We would prefer for you to have**:

- Good English oral and written communication skills
- Ability to work in a flexible environment to meet all regulatory requirements and business requirements
- Good organizational skills
- Experience with orphan developments in development setting
- Experience leading regulatory interactions
- Some travels might be required

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.

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