Head of Global Regulatory Affairs, Immuno Oncology

Woburn, MA

Head of Global Regulatory Affairs, Immuno Oncology 1116961

Job Scope & Purpose:

Our greater Boston area biotech client is seeking a Head of Global Regulatory Affairs in support of their clinical stage Infectious Disease program. This newly created role will execute key strategic initiatives as well as create future strategies for their pre-clinical pipeline in additional therapeutic areas. This impactful position requires technical proficiency, creativity, independent thinking, leadership, and a collaborative approach to advancing the company’s goals. The candidate’s regulatory experience should be broad, to ensure appropriate leadership within the company. By joining our client you will be a part of a passionate group of people committed to making a difference in the lives of patients.

Primary Job Requirements:

  • Experience interacting with global health authorities
  • Strong organizational and planning skills, with a proven ability to communicate effectively and efficiently with multiple audiences
  • Full functional knowledge of regulatory requirements (regulations, directives, and guidances/guidelines) pertaining to the development and registration of drug products in multiple regions and the ability to apply this knowledge to novel development programs
  • Flexibility with ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and adjust to new information or changing priorities
  • Ability to lead large global initiatives
  • Experience NDA/BLA and Global Health Authority submissions
  • Evidence of being a critical strategic thinker who is solution oriented with the ability and desire to think outside of the box; preference for demonstration of such within large global programs
  • Experience working collaboratively and cross-functionally at all levels across an organization
  • Demonstrated ability to motivate, mentor and manage a team in a matrix environment
  • Excellent written communication skills/technical writing experience
  • B.S. or graduate degree in life sciences preferred 
  • 5+ years of Regulatory Affairs experience within the pharmaceutical or biotech industries in multiple phases of development experience

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

sscheipers@stratacuity.com

Code: RegQA

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.