Director/Senior Director Regulatory Affairs
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective, and lower-risk drug development. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.
HUYABIO is seeking a self-motivated person to support regulatory affairs and regulatory operations for all aspects of HUYABIO’s global research and development efforts (“Director Regulatory Affairs”). The Director of Regulatory Affairs is responsible for assisting the VP of Regulatory Affairs with establishing and managing worldwide regulatory strategies, life cycle plans, pre and post regulatory approval of HUYABIO products and in-licensing candidates The Director of Regulatory Affairs is also responsible for oversight and execution of global regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, Designations, etc.) and regulatory compliance, including interfacing with internal and external consultants and with International Regulatory Authorities. This position would be held accountable for establishing strategic plans, policies and procedures to ensure HUYA fulfills its obligations and commitments and international regulations for drug development and marketing on assigned projects.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effect communication is critical for success.
Primary Duties and Responsibilities
- Establish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team members and representing the regulatory department in the development process
- Communicate requirements and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets
- Communication of regulatory strategies and plans to ensure alignment with the overall project plan and business strategy.
- Direct and lead regulatory execution of strategies and global regulatory submissions
- Contribute to compliance related functions such as GxP projects, governance initiation, draft and review SOP’s, review of contracts, quality and supplier agreements
- Oversight and management of external regulatory vendors and regulatory resources
- Lead the coordination of regulatory meeting packages and attend Regulatory Authority meetings as assigned
- Assist in the management and oversight of regulatory activities relating to clinical trials globally on assigned projects
- Assist with leadership of the regulatory team and provide guidance to the wider organization
- Advise on labeling, promotional review and other post marketing/commercial regulatory activities
- Assure compliance with global regulatory reporting requirements
- Represent the Company’s interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business in global markets.
- Perform other duties as requested and assigned
Job Qualifications and Requirements
- Comprehensive knowledge of current US and ex-US regulatory guidelines, and in-depth experience leading Regulatory in Global environments, including development of strategies, assessment of corporate risks related to regulatory and development activities
- Excellent knowledge of global regulatory, GxP, compliance, laws and regulations for pharmaceutical products
- Experience developing products globally, including INDs, CTAs, NDAs, MAAs, expedited approval pathways, etc.
- Proven ability to establish strategy and to translate it into an effective, long term action plan
- Demonstrated success in effectively leading regulatory teams
- Thorough understanding of the regulatory process from development through commercialization.
- Strong project management skills
- Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development, Regulatory and Quality Control
- Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
- Strong written and oral communication skills.
- Able to grasp complex technical issues and make sound decisions based on data and information from various sources
- Ability to foster and promote internal collaboration.
Education and Experience
- Advanced degree in Health Sciences or related experience with proven working knowledge of applicable regulations particularly in Japan, US, HC and EU markets
- Minimum 10 plus years’ experience gained in a pharma environment role, preferably in a Regulatory A minimum of 10 years at Senior /Director level.
- Experience with regulatory interactions preferably with FDA, EMA, HC and PMDA
- Preferably prior experience with both small molecule and biologics drug development
The position is full‐time, and the candidate must be available to attend company meetings and conduct business in person at HUYABIO’s Del Mar, CA office. Interested candidates should submit resumes to: email@example.com.