Associate Regulatory Affairs Director, Regulatory Science & Execution at Alexion in Boston, Massachusetts

Job Description:

Application reviews will resume the week of January 6th.


Happy holidays and New Year!


Support strategies and implement regulatory activities for assigned product and regulatory jurisdictions, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide operational and strategic regulatory input to cross-functional teams responsible for driving programs in relevant regulatory jurisdictions. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.



Accountabilities



Drive regulatory execution and implementation of regulatory strategies in the relevant regulatory jurisdiction, actively supporting relevant Regulatory Leads via the Regulatory Subteam (RSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.).


Contribute to the planning and conduct of regulatory authority meetings in relevant jurisdictions, providing input to submission strategy and other critical regulatory documents. May represent Alexion as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external collaborators.


Lead all aspects of operational activities and execution related to the Regulatory management in the relevant jurisdiction, in support of the Regulatory Lead, coordinating teams working on such deliverables.


Support Regulatory Lead and contribute actively to internal Governance and advisory bodies, or other relevant internal activities, including on the development and management of select Regulatory processes and procedures, as well as inspection/audit support.


Collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise.


Keep up to date on the latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment!



Essential Skills/Experience

• Bachelor's Degree, life science


• 6+ years of Regulatory experience in the pharmaceutical industry.


• Strong knowledge of drug development and regulatory policy, excellent scientific and business judgment.


• Lead regulatory activities in at least one regulatory jurisdiction (e.g. EU, US, China, Japan) for the global development of products through all stages of development including pre-approval and marketed assets.


• Manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.


• Build team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.


• Strong written/verbal communication skills.


• Proven track record practicing sound judgment as it relates to risk assessment


• Knowledge of new and emerging regulations and guidance's


• Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.

Desirable Skills/Experience

• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


Joining Alexion means embracing an opportunity where work isn't ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit - we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech. You'll join an energizing culture where people build connections to explore new ideas and learn. As an important member of our team, you'll meet the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You're supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.


Ready to make an impact? Apply now!



Date Posted

13-Dec-2024



Closing Date

30-Mar-2025Alexion 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 provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. Apply Now