Senior/Director, Regulatory Affairs, Rare Disease, 1110093
Job Scope & Purpose:
Our long-standing, rare-disease focused client is on the heels of their first approval and seeking a Senior/Director Regulatory Affairs to execute a key strategic role and join their impressive team. This impactful position requires technical proficiency, creativity, independent thinking, leadership, and a collaborative approach to advancing the company's corporate goals. The candidate's regulatory experience should be broad, to ensure appropriate leadership and mentoring of regulatory staff within the company. Reporting to the Vice President Regulatory Affairs and Quality, responsibilities include the development and delivery of science-based, solution-oriented, and internally aligned global regulatory strategies and tactical plans. The candidate in this role will provide technical and procedural regulatory guidance and leadership to key internal stakeholders to advance the development, commercialization and lifecycle of our clients products and help improve internal standards and systems. By joining our growing and dynamic Regulatory Affairs team, you will be a part of a passionate group of people committed to making a difference in the lives of patients we seek to serve.
Primary Job Requirements:
- B.S. or graduate degree in life sciences
- 10-15+ years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industries in multiple phases of development and multiple regions; both big and small company experience is preferred.
- International experience strongly preferred
- Strong organizational and planning skills, with a proven ability to communicate effectively and efficiently with multiple audiences
- Full functional knowledge of regulatory requirements (regulations, directives, and guidances/guidelines) pertaining to the development and registration of drug products in multiple ICH regions and the ability to apply this knowledge to novel development programs
- Flexibility with ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and adjust to new information or changing priorities
- Expertise leading global regulatory programs for products to treat rare diseases and/or unmet medical needs (eg, orphan products, fast track, breakthrough therapies, PRIME)
- Evidence of being a critical strategic thinker who is solution oriented with the ability and desire to think outside of the box; preference for demonstration of such within rare disease program
- Experience working collaboratively and cross-functionally at all levels across an organization
- Demonstrated ability to motivate, mentor and manage a team in a matrix environment
- Knowledge of pediatric drug development (both initial planning and life cycle management)
- Excellent written communication skills/technical writing experience
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.
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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.
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