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At Corner Therapeutics, Inc, our mission is to transform the standard of care, ushering in a new era of robust, rapid, patient-friendly and low-cost immunotherapies – even for the most difficult to treat diseases. Corner’s technology solves the “last mile” problem that has kept researchers from achieving the holy grails of medicine: therapeutic cancer and infectious disease vaccines that provide life-long immunity. With its antigen-agnostic platform, Corner is revolutionizing care for an exceptionally wide range of cancers and infectious diseases. Our dynamic workplace has tremendous opportunity for growth, and we are seeking talented individuals that are inspired and motivated to make exponential strides in curing disease through immunotherapy treatments.
The Role
Reporting to the Chief Medical Officer, the Director of Regulatory Affairs will be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area (TA). Your primary responsibility will be to expand TA knowledge and ensure strategic messaging and content of global regulatory dossiers. You will serve as the primary regulatory officer and interface with supporting teams to proactively anticipate and mitigate regulatory risks. You will ensure compliance with global regulatory requirements and manage compounds through all phases of development, starting at pre-IND phase. You will be responsible for developing and implementing acceleration strategies, manage projects and necessary documentation of regulatory strategies. Candidates should demonstrate excellent understanding of drug development and leadership behaviors consistent with level.
The Responsibilities:
* Ensure alignment of global regulatory strategies with Sr. Management.Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations.
* Leads cross-functional stakeholders to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
Leadership
* Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for team members, particularly as regards changing regulatory environment.
* Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
Responsibilities
* Act independently under the direction of supervisor to effectuate the Regulatory strategy in the form of writing, preparing and filing regulatory documents on-time and successfully.
* Organize, plan and prepare global regulatory product strategies and submission packages for assigned products and any subsequent responses to inquiries by regulatory agencies.
* Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders.
* Accountable for ensuring that corporate goals are met.Key internal leader and driver of regulatory policy and strategy for assigned products.
Follow company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures for regulatory affairs. May work collaboratively with AI-based platforms to optimize the assembly and review of submission packages, ensuring accuracy and reducing time-to-submission Follow budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional/consultancy services).
Preferred Qualifications
* Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
* Preferred Education: Relevant advanced degree is preferred. Certification a plus.
* Preferred Experience:7+ years’ experience in pharmaceutical regulatory activities; preferably in at least 2 regions/major countries. Experience developing and implementing successful global regulatory strategies, including IND submission. Strong clinical foundation preferred. Note: Higher education may compensate for years of experience.Experience in oncology, mRNA therapies or cell and gene therapies a plus.
* Experience working in a complex and matrix environment, and with multiple stakeholders. Proven experience interfacing with government regulatory agencies at early and late stage development. Experience working with Health Authorities.
* Strong communication and proactive negotiation skills. Business acumen and able to work under pressure.
The Culture:
We at Corner Therapeutics seek to attract individuals who believe in delivering exponential hope and impact for patients living with devastating disease.
Guided by a shared love of learning and aspirations for scientific excellence, we hold a common belief that work communities should be a place of diverse ideas, mindful focus and authentic fun. We take a shared ownership approach towards building and amazing people and patient-centric culture.
Game-changing science and bold business scaling can only be achieved when passionate people commit collaboratively to an extraordinary vision and to each other. We hope you will join us!
The Benefits:
Corner Therapeutics also seeks to build a robust total rewards and benefits package that supports the physical, mental and financial wellness of every team member with:
* Medical, Dental, Vision and company-supplemented Health Savings Account (HSA)
* 4 weeks' vacation (with roll-over available), 6 sick days, 2 floating and 14 paid holidays
* Generous parental leave policy
* 401K with company match
* Long-and short-term disability, Life insurance
* Annual Tuition reimbursement (up to $5,250)
* Professional Development Training & Resources
* Free Parking
Corner Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
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