Assoc Dir, Regulatory Affairs

Job Location:

Zurich, Zurich, Switzerland

Job Description:

 

 

Associate Director, Portfolio Products, Global Regulatory Affairs    

Reports to: Executive Director, Regulatory Affairs

Location: Zürich, Switzerland or Boston, MA

 

 

Position Summary

The Associate Director, Regulatory Affairs 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.

Principal Responsibilities

  • 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 aspects of US regulatory affairs, and ensures integration into global regulatory strategy.
  • Represents Alexion as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development. 
  • Coordinates submissions to FDA in support of proposed and ongoing development programs, e.g., new IND submissions, IND 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.

     

     

    Qualifications

  • 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.

     

    Education

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

 

Competencies

  • Ensures Accountability
  • Collaborates
  • Decision Quality
  • Cultivates Innovation
  • Being Resilient
  • Learning and Self-Development

 

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. 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.

Alexion is an Equal Opportunity /Affirmative action employer    

 

 

 

 

Zurich, Switzerland
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.



Apply for this job at https://alexion.contacthr.com/59598007

Contact Information:

Contact: Alexion
Alexion

Posted:

December 28, 2017
UID: 59598007

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