Specialist, Regulatory Affairs Management at Alexion in Boston, Massachusetts

Job Description:

The Specialist, Regulatory Affairs Management (RAM) will support the strategic development and execution of regulatory activities for assigned products and regulatory jurisdictions with a goal of achieving registrational approval from governmental authorities and post approval life cycle management.


The successful candidate will:

• Provide operational and strategic regulatory input to cross-functional teams responsible for executing programs in relevant regulatory jurisdictions
  
  


• Ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities
  
  


• Provide ad hoc support to cross functional teams or internal Regulatory Affairs department, where necessary
  
  

Primary Responsibilities:

• Support members of the Regulatory Sub Team (RST) to deliver business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.)
  
  


• Oversee the coordination and execution of operational activities to ensure program deliverables are submitted on time
  
  
  
  
  • Support and contribute to internal governance, advisory or other relevant internal activities, to assist with 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
  
  


• Proactively stay abreast of the latest regulatory requirements and trends, and ensure information is shared with members of Regulatory Affairs department to assist with the shaping of the regulatory science environment
  
  

Qualifications

• Bachelor's degree in a scientific or regulatory affairs with at least 5 years relevant experience
  
  


• An understanding of regulatory processes and regulations, across all stages of drug development (preapproval, authorization and post marketing)
  
  


• Ability to manage multiple stakeholders and build team relationships to collaborate in a global team environment at all levels of the organization
  
  


• Experience managing regulatory activities for the global development of products through all stages of development including pre-approval and marketed assets
  
  


• Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organization
  
  


• Excellent written and verbal communication skills
  
  


• A proven track record of leadership and project management in regulatory affairs is required
  
  


• Strong strategic and technical regulatory knowledge, with long-term and global vision
  
  


• Understanding of GxPs in relevant areas and 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 officebased 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 nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours



Date Posted

16-Oct-2024



Closing Date

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 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.


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