Regulatory Affairs Consultant (Onsite) in Waltham, MA at APEX Systems

Date Posted: 9/14/2019

Job Snapshot

Job Description

Job #:  994384
Regulatory Affairs Consultant, Biopharma, 994384
Job Scope & Purpose:
Our client, a rare-disease focused biotech in Waltham is searching for an experienced Regulatory Affairs Consultant (Sr. Manager/Associate Director) to join their growing team. If you have 5+ years of Reg Affairs experience in a biotech/pharmaceutical setting with previous experience in rare disease continue reading and consider applying today!
Primary Job Responsibilities:
  • Liaise with Project Teams to ensure deliverables are met
  • Review, manage and organize documentation for regulatory submissions
  • Help define regional and country-specific regulatory requirements in major global markets and develop strategies to support clinical trial applications. Support ex-US submissions (led by CROs) by providing guidance and core documents at study start. 
  • Track and respond to queries during the review and approval process.
  • Monitor emerging trends regarding industry regulations and maintain awareness of evolving regulatory requirements or developments.
  • Conduct gap analyses and regulatory risk assessments. 
  • Develop mitigation strategies to ensure that program activities are appropriately designed and implemented to meet global regulatory requirements.
  • Identify and respond to regulatory issues.
  • Help develop and implement departmental operating procedures.

Primary Job Requirements:
  • BS, MS, or advanced degree in the life sciences
  • RAC certification is a plus
  • 5+ years of experience in Regulatory Affairs for drugs and/or biologics
  • Experience successfully executing regulatory activities in the US, EU, and globally required
  • Experience working in rare disease therapeutic area is a plus 

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.
asobel@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 844-463-6178-6178.