Alexion Pharmaceuticals Vice President, Global Regulatory Affairs - Development Strategy, Alexion in Boston, Massachusetts
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 Vice President, Global Regulatory Affairs Development Strategy (GRA-DS) is responsible for leading the team of regulatory strategy professionals who develop and implement 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 position takes a central role in the RQA Leadership Team, contributing to RQA objective definition, general management, and setting the appropriate cultural tone across the department. As an Enterprise Leader, this individual contributes to the definition and delivery of the Alexion Rare Disease Business Unit leadership objectives.
You will be responsible for:
Developing Alexion’s overall regulatory strategic capability through effective leadership of the Development Strategy team. Fostering an inclusive environment of continuous improvement, open and effective communication, and personal development, across GRA-DS.
Providing strategic guidance to regulatory professionals across GRA-DS, through regular reviews of key development issues and ad hoc input on specific strategic topics.
Ensuring appropriate resourcing for GRA-DS Therapeutic Area teams and monitoring workload across programs in collaboration with GRA-DS TA Leads.
Monitoring the development of new regulatory requirements or guidance documents and advises product team representatives of the impact on the business or development programs Providing 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.
Actively participating as a member of the RQA Leadership Team.
May represent RQA on assigned Alexion governance and leadership teams, e.g., GATM Review Committee, Clinical Document Review Committee, Enterprise Leadership Team, and R&D TA strategy reviews.
May represent Alexion on external policy committees (e.g., PhRMA, BIO, etc.)
You will need to have:
Bachelor’s Degree in a related discipline
15 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 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.
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.
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. Further information about Alexion can be found at: www.alexion.com .
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, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
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, and much more.
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 (https://careers.astrazeneca.com/) .