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: Manager/ Sr Manager Regulatory Affairs Strategy
Reports to (Title): Regulatory Strategy Lead, Oncology, Sr Director
Direct Report: No
Department: Global Regulatory Affairs
EEO Job Category: Professional
Manager or Sr Manager, Regulatory Affairs Strategy Oncology, is responsible for executing regulatory tactics and strategies for all assigned products with the intention of achieving with the team successful registration and life-cycle management of unique and technologically complex products helping patients with cancer. This individual will, with a high sense of urgency, work together as a key team member with regulatory professionals to provide operational and timely regulatory input to cross-functional teams responsible for development programs. The individual will also be responsible, together with other team members, for project management, communication and constructive working relationships with business partners and representatives of regulatory authorities.
Essential Job Functions:
Under the leadership of the Head of Global Regulatory Affairs, SVP and the Senior/Executive Director, this Manager or Senior Manager is responsible for:
- Coordinate regulatory submissions for assigned projects, including tactical and strategic support, and executing tactics and strategy at the team level, for development of projects in oncology, aligned to overall R&D objectives from early development, through initial registration and as appropriate subsequent global expansion, and including implementation of new indications and formulations.
- Work together as a team member to collaborate with management and cross functional colleagues (including clinical development, drug safety, nonclinical and research and development, CMC, medical affairs, business development) on regulatory submissions, regulatory insight for assigned projects, and advancing drug development.
- Collaborate with cross functional team as a key team member, responsible for project management, coordinating resourcing and balancing project support across portfolio products developed for oncology indications. Provide submission planning support on project teams.
- Assess and evaluate adequacy of the submission’s contents based on filing objectives and regulatory requirements, according to type of regulatory authority, and global region/country
- Represents the team and the company in contact with US FDA when feasible on assigned projects. When appropriate, as assigned, will act as Company’s regulatory delegation to support the regulatory meetings.
- Build positive relationships with FDA and other Regulatory authorities to ensure health and safety of patients.
- Monitor the development of new regulatory requirements or guidance documents. Work with the team to assess the impact of new regulations, guidance or enforcements and bring updates to the broader Regulatory Group on requirements to maintain compliance with regulatory operations activities and on the impact to the business or development programs.
- When assigned, will provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
- Foster collaborative, efficient, and effective working relations with internal and external colleagues to further build the cordial working relationship between Company and overall organization.
- Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies.
- Other activities as required.
- Prior experience in the biotechnology and/or pharmaceutical industry in successful preparation and submission of Meeting Requests, Clinical Trial Applications, and related submissions.
- Experience with preparing/ supporting for formal meetings, key submissions under 505(b)(1), post-approval life cycle management with major clinical supplement filing experience is a plus
- Appropriate knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA and FDA guidelines as appropriate for level
- Potential for development of leadership qualities including leading teamwork, strategic thinking, innovation, influencing, scaling and collaboration
- Excellent regulatory operations skills, including planning and organizing. Project Management skills with proficient experience is a plus.
Experience / Education
- Bachelor’s or Advanced degrees in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields.
- 5+ years of relevant biopharmaceutical industry regulatory experience, with 3+ years’ experience in new drug development with at least 2+ years of experience in Oncology.
- Practical Knowledge of US regulatory pathways i.e., 505b1, and PHS 351(a) required.
Knowledge / Skills / Abilities:
- Knowledge of drug development and regulatory policy; excellent scientific and business judgment.
- Ability to learn the process of providing strategic regulatory advice for the development of products through all stages of development including pre-approval and marketed compounds.
- Ability to develop the skills of managing complex issues and coordinate multiple projects simultaneously
- Work together in intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.
- Excellent interpersonal and written/verbal communication skills in English.
- Sensitivity for multicultural/multinational environment and understanding of the global pharmaceutical development process
- Ability to learn sound judgment as it relates to risk assessment
- Desire to learn new and emerging regulations and guidance’s, including understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information
- Willingness to assess the competitive landscape
- Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills.
- Working knowledge of global regulatory requirements and submission processes.
- Good interpersonal skills that involve working well in a team environment and the ability to lead and influence others.
- Collaborative and good organizational and planning skills; results driven.
- 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 apply here