Associate Director Global Regulatory Affairs Development Strategy

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.

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:

• Works 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.
• Provides 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.).
• Prepares and executes region-specific aspects of regulatory affairs, and ensures integration into global regulatory strategy.
• Represents Alexion as point contact with regulatory authorities, including providing support for and coordination of regulatory meetings and information package development. 
• Coordinates 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 Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
• Ensures exemplary behavior, ethics and transparency within the company and with regulatory agencies.

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.

You will need to have:

• 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 including pre-approval and marketed compounds.
• 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.

• Bachelor’s Degree in a related discipline
• 7 years in pharmaceutical industry regulatory affairs

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.

Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status (including adoption or surrogacy), pregnancy (including childbirth, breastfeeding, or related medical conditions), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees. 

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families.

Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.