SVP Regulatory Affairs

Company: Apex Systems
Location: Boston
Posted on: June 12, 2021

Job Description:

Senior Vice President, Global Regulatory Affairs 1140204

Job Scope & Purpose:

Our unique and accomplished Biotech client is in search of an SVP, Global Regulatory Affairs with a broad skillset across various therapeutic areas, including oncology and rare diseases. This role will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development from pre-clinical assets through approval. This is an opportunity build, lead, and develop a high functioning and diverse regulatory team for the organization.

Primary Job Responsibilities:

• Direct global clinical, non-clinical, and CMC regulatory strategies
• Provide regulatory guidance throughout the research and development process
• Identify and assess regulatory risks & define strategies to mitigate such risks
• Prepare clear and effective regulatory submissions on behalf of the organization leveraging internal and external resources
• Prepare and lead meetings with US and Global Health Authorities
• Be the primary contact with regulatory bodies in US and Global Health Authorities
• Build and maintain excellent relationships with relevant regulatory agencies
• Supervise, interact with and/or coordinate with regulatory staff and external vendors to ensure adequacy of project support and deliverables.

Primary Job Requirements:

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements for early and late stage development programs
• Experience across several therapeutics areas, including oncology and rare diseases
• Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project
• Solid knowledge of GCPs and GLPs
• Direct experience in interfacing with relevant regulatory authorities
• Experience and comfort with a small biotech company environment
• Demonstrate excellent leadership and communication skills
• Demonstrate strong organizational skills, including the ability to prioritize personal workload
• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
• Experience with eCTD, e-publishing systems for preparing regulatory submissions

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.

Keywords: Apex Systems, Boston , SVP Regulatory Affairs, Other , Boston, Massachusetts