Job Scope & Purpose:
If you’re an experienced Regulatory Affairs professional with Biologics expertise, we have an exciting Director level Regulatory Strategy role to discuss with one of the most exciting company’s in Biotech. You will serve as the global regulatory lead for assigned programs for our client’s cutting edge programs, and provide expert interpretation of requirements relating to the development and licensing of biopharmaceuticals and communication to cross-functional teams to create innovative regulatory strategies for targeted biologics to treat cancer. Furthermore, you will represent our client before health authorities.
Primary Job Responsibilities:
Develop and execute innovative global regulatory strategies for assigned programs
Provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
Develop and manage regulatory submissions and related supplements and amendments
Responsible for maintaining and updating the regulatory strategy document and target product profile for assigned programs.
Interacts directly with health authorities and maintains excellent relationship with regulatory personnel.
Adept at integrating biomarker/companion diagnostic strategies into the development of assigned programs.
Provides regulatory due diligence assessments of new business opportunities.
Hire and develop a strong regulatory professionals
Primary Job Requirements:
Advanced degree in a scientific or health-related field
10+ years of regulatory affairs experience in the biopharmaceutical industry
Experience in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy for assigned programs
In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions
Experience with development of biomarkers and IVD companion diagnostics devices
Strategic thinker with excellent problem solving and influencing skills
Exceptional communication and presentation skills to ensure the regulatory strategy is clearly articulated in cross-functional teams
Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities
Track record of building an excellent relationship with the FDA and other regulatory agencies
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 at email@example.com or 877-787-2821.