Apex Systems Looking for Head of Regulatory Affairs at Cambridge, MA Full Time

Job Description:

Head of Regulatory Affairs 1269411

Job Scope & Purpose:

We are excited to partner with a new global oncology focused biotech that is looking to add a Head of Regulatory Affairs to their organization. While the company is Boston based, they are open to this person being remote (EST) with periodic travel to HQ for meetings. Reporting into the CMO, this individual will provide global regulatory leadership and strategic direction across all programs.

This is a great opportunity for an experienced regulatory professional to join a well-established organization with the opportunity to create their own vision and build out a regulatory team.

Primary Job Responsibilities:

• Provide Regulatory leadership for the Global Regulatory team across all programs, providing strategic direction for the advancement of the company pipelines, with emphasis on the global trial development and roadmap
• Formulate and oversee implementation of regulatory strategy and activities
• Lead, plan, and manage high-quality deliverables for all regions (US / Global)
• Develop and maintain relationships with external vendors and regulatory health authorities
• Contribute to the growth of the Regulatory Department, including development of regulatory systems and processes to support the team
• Maintain and amplify knowledge of global regulatory requirements and relevant new intelligence with the wider Regulatory team as needed
• Build and mentor the Global Regulatory team to ensure high quality output and to foster personal career growth for all team members

Primary Job Requirements:

• Doctorate or Master’s degree (or equivalent) in relevant scientific field
• At least 6-8 years of regulatory experience in the biopharmaceutical industry and a minimum of 1-3 years of management/leadership experience
• Strong Oncology background
• In-depth knowledge of drug development process and regulatory requirements
• Prior NDA and/or BLA initial application development experience
• A proven track record of effective collaboration with the FDA and EMA (knowledge of FDA CN and post-marketing – a plus)
• Able to understand and interpret complex scientific issues and data sets across multiple programs as it related to regulatory requirements and strategy

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.

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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 or .