Website Luzsana Biotechnology
Luzsana Biotechnology™ (Luzsana) is a global, purpose-driven innovative medicines company with the mission to deliver medicines that are available, accessible, and affordable to anyone, anywhere. The origin of the Luzsana name is rooted in “la luz,” which is Spanish for the light, and “sana,” which is Latin for heal.
Luzsana is a healthcare company that aspires to become a “healing light” across the biotech sector by prioritizing the well-being of all stakeholders it encounters while operating its business. Through a strategic plan with its parent company Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), Luzsana co-develops innovative medicines in areas of high unmet medical need for commercialization in North America, Europe, and Japan.
The company’s pipeline currently includes 11 high-potential oncology and non-oncology programs that span all stages of development from preclinical to phase 3, which it intends to further diversify over time. These programs aim to address areas of high unmet medical need, some with first-in-class or best-in-class potential.
We recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing organization and to be part of a team where they are respected, engaged, fulfilled, and developing!
Job Title: Sr./ Director, Regulatory Affairs, US Lead Oncology
Reports to (Title): Global Head of Regulatory Affairs, SVP (Direct)
Location: New Jersey, Remote
Direct Reports: Yes
Department: Global Regulatory Affairs
EEO Job Category: Professional
The US Regulatory Affairs Lead is responsible for developing and implementing innovative and robust US regulatory strategies for all assigned products within Luzsana’s growing oncology portfolio with the intention of achieving successful registration and life-cycle management of unique and complex products serving patients with cancer. He/ she will be accountable for the efficient and effective execution of US regulatory strategies while adhering to US regulatory and company guidelines.
This individual will, with a high sense of urgency, lead a team of regulatory professionals to provide operational and strategic regulatory input to cross-functional teams responsible for development programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Essential Job Functions:
- Serve as Luzsana’s liaison to the US FDA for assigned oncology projects in clinical development.
- Lead the strategic development of documentation submitted to the US FDA and lead FDA meetings and negotiations.
- Represents the US GRA perspective as a member of the project specific cross functional team (GPT).
- Develops and maintains the US regulatory strategy documents and advise on US regulatory issues at internal meetings.
- Works with and participates on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products.
- Participates in the development and monitoring of the US regulatory environment and provide updates related to drug and biologics US regulations.
- Manages relevant regulatory activities including but not limited to IND, ODD, iPSP, and NDA/ BLA filings via standard and expedited pathways.
- Actively collaborate with management and cross functional colleagues to provide oncology portfolio related regulatory insights and US specific drug development expertise.
- Represents the company as point contact/ primary regulatory liaison of the responsible projects with the US FDA reviewing divisions. Leads company delegation and facilitates, regulatory meetings.
- Keep current knowledge of regulation updates. Monitor the relevant regulatory landscapes and development of new regulatory requirements or guidance documents and advises project teams of the impact on the business or development programs.
- Provide support for due diligence initiatives, including regulatory intelligence, opportunity and risk assessment.
- Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
- Assesses the impact of new regulations, guidance or enforcements and advise the broader Regulatory Group on requirements to maintain compliance with regulatory operations activities.
- Monitors, assesses, and maintains current awareness of evolving regulatory landscape, regulations and guidance documents; apprises management of the impact of these changes.
- Coach and mentor junior staff supporting regulatory team.
- Fosters collaborative, efficient, and effective working relations with internal and external colleagues to further build the cordial working relationship between Luzsana and overall organization.
- Other activities as required.
- Must have substantial experience and a successful track record in oncology within the biotechnology and/or pharmaceutical industry in successful preparation and submission of late phase INDs, Formal Meetings with the FDA, ODD, PSP, NDAs/BLAs and supporting GMP inspections
- Current substantial knowledge & experience in US oncology regulatory development.
- Accelerated application submission and approval experience in oncology strongly desired.
- Strong updated knowledge of current Good Manufacturing Practices (cGMP), Good Clinical practice in oncology drug and biologics development regulations and guidelines including ICH, FDA guidelines.
- Strong leadership qualities including strategic thinking, innovation, coaching, mentoring, scaling and collaboration
Experience / Education
- Advanced degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields.
- 15+ years of relevant biopharmaceutical industry regulatory experience, with 10+ years oncology experience during new drug development.
- Recent oncology strategic experience with NDA/ BLA approval and AA experience are highly desirable.
- Practical Knowledge of update to date FDA considerations required.
Knowledge / Skills / Abilities:
- Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
- Experience providing strategic regulatory advice for the development of products through all stages of development including pre-approval and marketed compounds.
- Ability to manage complex issues and coordinate multiple projects simultaneously
- Highly ethical with ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.
- Strong interpersonal and written/verbal communication skills.
- Proven track record practicing sound judgment as it relates to risk assessment
- Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information
- Good interpersonal skills that involve working well in a team environment and the ability to lead, coach and influence others.
- Collaborative and good organizational and planning skills; results driven.
- Excellence in written and oral communication.
- Effective analytical/problem solving skills.
- Ability to interpret global regulations, scientific and technical journals and legal documents.
- Ability to write procedures.
- Ability to effectively present information to internal and external partners.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
If you’re interested, please directly apply to the company site here