Director/Associate Dir Regulatory Affairs - Oncology & Rare in Lexington, MA at APEX Systems

Date Posted: 11/19/2019

Job Snapshot

Job Description

Job #:  1026282
Director/Associate Dir Regulatory Affairs - Oncology & Rare, 1026282
Job scope & Purpose:
Our established client focused on treating diseases using RNAi-based therapeutics, is seeking an experienced and enthusiastic Director/Associate Director Regulatory Affairs Project Manager to join their growing team! This newly created role will be responsible for project management activities including planning, coordination, and execution of high-quality regulatory submissions of original applications (i.e. NDAs, MAAs, INDs, IMPDs, CTAs) and any subsequent major amendments, supplements, and variations for assigned programs. This individual will have the opportunity to establish and implement processes for planning Global Health Authority submissions.
Primary Job Responsibilities:
  • Responsible for partnering across Regulatory (Strategic Regulatory, Medical Writing, CMC Regulatory, Ad-Promo Regulatory and RegOps) and with cross-functional project teams to ensure regulatory timelines and strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities.
  • Facilitates and co-leads product/submission-specific multi-disciplinary, cross-functional teams, working with all major contributors, including, but not limited to Regulatory, Medical Writing, Preclinical, Biostatistics, CMC, QA, etc. to set expectations and ensure timelines are met.
  • Identify and communicate both regulatory and project risks, with potential solutions to cross-functional project team and leadership as needed.
  • Prepare meeting agendas, meeting minutes and document decisions, action items and effective issue and risk mitigation plans. Organize and maintain this team information in a central location.
  • Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables. 
  • Manage the review cycles and any follow up round tables as needed per the filing timelines.
  • Plan, manage, attend and prepare for Regulatory Health Authority interactions and assist in documenting meeting minutes.
  • Develop and implement plans for aligning key strategic messaging across submission components.
  • Create policies and Standard Operating Procedures for processes related to global submissions
  • Conduct lessons learned sessions to identify areas for improvement.
  • Provide senior oversight, influence, and guidance to other submission project managers.

Primary Job Requirements:  
  • Bachelor’s degree in a scientific discipline. Advanced degree preferred
  • 10+ years of experience working in the pharmaceutical industry and substantial experience working within Regulatory Affairs with a fluent understanding of drug development
  • Qualified project management experience; advanced expertise with MS project
  • Prior project management experience with NDA/BLA submissions and review is required
  • Demonstrated experience in leading decision-making within cross-functional teams

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. 
jprice@stratacuity.com
 
Code: ClinOps
 
 
 
 
 
 
 
 
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.