VP/Sr. Director Regulatory Affairs - Immuno-Oncology in Waltham, MA at APEX Systems

Date Posted: 7/12/2019

Job Snapshot

Job Description

Job #:  965553
Senior, Director of Regulatory Affairs, Immuno-Oncology 965553
Job Scope & Purpose:
Are you a senior oncology-focused Regulatory Affairs professional seeking innovative I/O-focused science and a fantastic culture?  Our high profile client is growing their clinical presence as they prepare to enter the clinic.  This discovery-stage company is developing drugs to stimulate immune responses against cancer, and the molecules are expected to be potent as single agents as well as in treatment combinations with existing cancer immunotherapies. Our client’s scientific founders are major figures in cancer biology and immunology and the therapies are poised for success!
The Regulatory Affairs Lead will be responsible for ensuring the development and delivery of solution-oriented and globally aligned regulatory strategies. The position will ensure the alignment of regulatory plans with the company’s corporate objectives and will oversee all aspects of regulatory document preparation and submissions for our immune oncology programs. Strong candidates will have the desire to proactively participate within a cross-functional team of internal and external colleagues, CRO partners, experts, and investigators. The successful candidate will work with our client’s talented team to discover and develop therapies that stimulate immune responses against solid and hematologic cancers.
Primary Job Responsibilities:
  • Provide strategic global regulatory perspective during the development, review, and approval of internal and external documentation to support development programs
  • Collaborate with key internal stakeholders to ensure the global regulatory strategy is incorporated and implemented in line with program objectives
  • Manage the content of global regulatory dossiers. Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle approvals
  • Ensure compliance with global regulatory requirements. Work to resolve regional conflicts in global regulatory strategies and oversee critical deliverables to all territories
  • Represent the company at key regulatory agency meetings; moderate and lead discussions
  • Develop and maintain effective relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes
  • Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory procedures, changes, and trends
  • Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions

 
Primary Job Requirements:
  • Degree in a scientific discipline, or equivalent; Regulatory Affairs Certification preferred
  • Minimum of 15 years of industry experience; 8 years of direct regulatory affairs experience in the conduct of FDA-regulated clinical trials, oncology experience preferred
  • Extensive experience with global regulatory processes, documents, and requirements (eg, INDs, clinical trial applications, marketing applications, meeting request procedures, and materials
  • Excellent interpersonal skills with the ability to build strong relationships across multiple functions and organizations
  • Ability to work independently and with the flexibility to handle workflow in a fast-paced environment
  • Excellent verbal, written, and interpersonal communication skills

 
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: RegQA
 
 
 
 
 
 
 
 
EEO Employer
Apex 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. 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.