Associate Director Regulatory Affairs

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:  Associate Director Regulatory Affairs

Reports to (Title): Exec Dir Regulatory Affairs, Oncology,

Location: Princeton, NJ

Exempt/Non-Exempt: Exempt

Direct Reports: Yes

Department: Regulatory Affairs

EEO Job Category: Professional

As an Associate Director, Regulatory Strategist working on the Regulatory Affairs Oncology team, you will be defining, developing, and leading strategies to maximize regulatory success towards achievement of program objectives.

SUMMARY:

The associate Director is responsible for the development, implementation, and maintenance of US regulatory strategies and collaborates with co-development partners on global regulatory strategies. He/ she is a regulatory leader of the assigned projects contributing to cross-functional initiatives and influencing the field as applicable.

Responsibilities:

• Provide actionable Regulatory Input to teams into Development Strategy to enable timely and desirable registrations across all target regions.
• For assigned projects, leads the Regulatory Team and applicable sub-working groups, such as the Label Working Group and Submission Working Group, and represents Regulatory Team at project team meetings
• Ensures project team colleagues, line management, and key stakeholders are apprised of developmentsthat may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
• Advise team on specific requirements or gaps in clinical program to support submission and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements).
• Responsible for ensuring complete submission of INDs, ODD’s, BTD, Fast Track, PSP’s, safety reporting, meeting request, briefing packages and other relevant submissions when appropriate.
• Coordinates with cross functional teams and manages the preparation of responses to regulatory agency queries. Monitor/ oversees completion of activity by others to ensure timely response.
• Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed
• Supports major submissions (NDA/BLA/MAA) when needed.
• Strategize with Regulatory Team Lead and other core members on the regulatory strategy for NCEs and major amendments to foster one regulatory voice.
• Leads or supports highly complex or multiple projects within the oncology group.
• Seek and apply innovative regulatory approaches to accelerate development and approvals.
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives.

Requirements

• Scientific background with a minimum of a Bachelor’s degree (PhD, MD, PharmD, Masters, desired). A Bachelor’s degree and at least 11 years experience, or an advanced degree and a minimum of 9 years Regulatory Affairs experience and 5 years in oncology therapeutic area in pharmaceutical industry.
• Experience with understanding and advising regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience with communicating regulatory strategy, issues, and risks in written and verbal format to multiple stakeholders (Health authority, Clinical Development, Clinical Pharmacology, Biostatistics, Pharmacovigilance, etc.)
• Experience coordinating communications within teams and across functions.
• Effectively manage meetings and drive plans while functioning remotely.
• Experience applying project management techniques within teams.
• Experience in companion diagnostics development is a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in establishing and building appropriate regulatory strategy.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies

Key Requirements

• Demonstrated ability to break down complex, scientific content into logical components.
• Understanding of tactical role of Regulatory liason in the drug development process.
• Demonstrated ability to organize / prioritize tasks and facilitate issue resolution.
• Understanding of Product Development and associated specific responsibilities / deliverables.

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 apply here.