Job Detail

Executive Director, Regulatory Affairs INTERNATIONAL

Req ID: 14971
Job Category: Regulatory Affairs
Location: Zurich, Zurich
Posting Date: December 4, 2018

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Executive Director, Regulatory Affairs INTERNATIONAL

Reports to : SVP, Global Regulatory Affairs 

Location : Zurich, Switzerland

Position Summary

• The Executive Director, Regulatory Affairs, International will have direct responsibilities for all RA activities at the affiliate level within EMEAC and drives a culture of excellence in the  newly created“International” zone regulatory team (EMEA + Canada + APAC + LATAM)


• This individual will provide regulatory leadership and a sense of urgency to cross-functional teams responsible for global programs and ensure effective communication and constructive working relationships with business partners and representatives of regulatory agencies


• This position will play an integral role in coordinating local registrations, product launch and compliance with local obligations


• The Executive Director, Regulatory Affairs, International is a member of International EMT and will act as a deputy to the SVP of Global Regulatory Affairs with regards to the EMEAC region

Principal Responsibilities

• Line function management of local regulatory leads in International


• Ensure local regulatory requirements are fulfilled in each country in the  International region

• ensure internal regulatory processes and procedures are well documented – Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution

• Work in close collaboration with International and global RA leadership team to define priorities


• Mentor and develop staff of regulatory professionals and assign regulatory affairs representatives to serve as global team and sub-team regulatory leaders as needed.


• Serve as advisor on regulatory issues for both marketed and pipeline products; actively collaborate 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.).


• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.


• Provide regional specific advice regarding post-marketing and promotional activities to Legal, medical and regulatory review (LMR) committee


• Provide input into draft Guidance’s and policies, working closely with global government affairs staff.  Serve as Alexion senior regulatory affairs representative on relevant EMEA, LATAM and APAC trade association teams as assigned.


• Identify and escalate any unresolved regulatory affairs compliance concerns to the SVP, Global Regulatory Affairs


• Work closely with quality and Identify audit needs in the regions and follow up on CAPAs


• Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies


• Contribute to local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention.

Qualifications

• 15+ years of experience in Regulatory Affairs within the pharmaceutical industry


• Strong track record in line management & cross-functional leadership


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


• Understanding local regulations and trends for assigned markets (International)


• Ability to manage complex issues and coordinate multiple projects simultaneously


• Ability to build team relationships and collaborate in a global team environment at all levels of the organization.  Adept at change management


• Strong interpersonal, communication and leadership 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

   

Education

• Master’s degree required. PharmD or PhD preferred

As a leading employer in our industry, Alexion is proud to offer 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. To learn more about Alexion, please visitwww.alexionpharma.comor download our App for iPhones and Blackberries.