The primary responsibility of the CMC Regulatory Affairs Associate Director is to provide CMC RA supports for the submissions in China with a focus on chemical products. He/she will also support chemical product CMC strategy development and implementation across product full life cycle in China. He/she will be involved in communication with global CMC RA and CPDS functions to ensure adequate support for the registration testing at NIFDC or PFDA Laboratories. He/she will be involved in communication with global CMC RA and China RA product owners to ensure adequate supports for the challenges in drug registration. He/she should support China CMC RA Head to build a closer connection with NMPA and influence the local regulatory environment. He/she will participate in RDPAC task forces and activities and comment on NMPA new regulations.
Responsibilities may eventually expand to include a role to provide timely regulatory risk assessment due to various CMC variations along with China RA product owners to products marketed in China. Based on a broad regulatory and technical expertise, he/she will also provide guidance to local, regional and/or global associates, ensuring that CMC regulatory and development strategies are consistent with evolving expectations of NMPA. CMC RA
- Provide supports to CMC RA activities that include development of submission CMC strategy and support preparation of CMC dossiers in compliance with Chinese Pharmacopeia.
- Support development of CMC dossiers to meet local regulatory requirements over the lifecycle of products imported into China
- Escalate issues that affect registration, regulatory compliance and continued lifecycle management of the products imported into China to CMC RA Head
- Participate in technical and regulatory discussions for preparation of regulatory CMC dossiers for submission to NMPA
- Support regulatory assessments of CMC changes to teams/projects and regulatory planning and implementation
- Assure connectivity to the overall local regulatory strategy through communication with CMC RA product responsible colleagues and project team members
Principle responsibilities for CMC Regulatory Associate Director:
- Develop local CMC regulatory strategy in support of drug registration in China
- Represent CMC Regulatory viewpoint and expertise associated with regulatory risk assessments and mitigation strategies that affect local registration, regulatory compliance and continued lifecycle management of the imported products and the products manufactured at Xi’an Plant
- Develop and get buy-in on regulatory CMC strategy for NMPA and PFDA as needed
- Communicate with global CMC RA to ensure the development strategies are consistent with evolving expectations of NMPA
- Support development of CMC regulatory strategy for CTA and NDA filed in China
- Proactively influence ChP 2020 and China new regulations by participating activities in RDPAC and other trade associations
- Develop a good working relationship with CDE of NMPA to support CTA and NDA submissions in China. Promote ICH guidelines in drug development and CMC content preparation
- Support China RA product owners to ensure the CMC dossiers to meet China regulation and ChP
- Support of submissions to NMPA or Shaanxi PFDA and provide strategy as issues arise to gain rapid approval with reasonable risk
- Support CMC RA Head to work with CMC RA and PDMS DDO to develop and maintain CMC dossier for CTA and NDA submissions in China; able to prioritize based on business impact
- Provide support in CMC dossier preparations for the new drug developed at China R&D or from global pipeline.
Health authority Interactions
- In collaboration with global CMC regulatory leaders, as applicable:
- Support regulatory meetings with Health Authorities in AP region, as required
- Support regulatory meetings with China NMPA or PFDA
- Ability to negotiate with HA personnel on CMC strategy, content requirement, and QC testing challenges
- Support preparation of responses to NMPA or PFDA questions (ensure alignment with local /global strategy)
- Effectively and tactfully communicate with NMPA and PFDA; maintain good rapport and credibility with the Agencies
- Actively influence the future CMC regulatory environment through direct interaction with NMPA and PFDA
Regulatory Input into Other Functions
- Support regulatory risk assessment for the marketed products in China
- Support regulatory assessments of CMC variations impacting filings from Xi’an Plant
- Provide input to pharmaceutical development, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the submissions to NMPA and Shaanxi PFDA
Required Leadership Competencies:
- Integrity and Credo Based Actions: lives Credo values; builds trust; tells the truth; initiates transparency into issues/concerns; demonstrates genuine caring for people
- Strategic Thinking: driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; motivated to leave things better than they were; a change agent. The ability to identify patterns or connections between situations that are not obviously related, and to identify key or underlying issues in complex situations; includes using creative, conceptual or inductive reasoning.
- Collaboration & Teaming puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires followership; instill a global mindset; champions best practices
- Sense of Urgency proactively senses and responds to problems and opportunities; works to reduce cycle time; takes actions when needed
- Results and Performance Driven/Initiative assumes personal ownership and accountability for business results and solutions; the ability to identify a problem, obstacle or opportunity and take action to address current or future problems or opportunities; consistently delivers results that meet or exceed expectations; keeps focus on driving customer value.
- Prudent Risk Taking: makes decisions based on facts; challenges the status quo to identify ways of doing things better and faster; encourages others to achieve innovative results; inner confidence to take risks and learn from experience; willing to make tough calls.
Required Technical Competencies & Knowledge:
- Regulatory Strategy
Understanding of worldwide health authority laws, regulations, and guidance
Understanding of global regulatory procedures available to study new drugs.
Knowledge of competitors in the area and what they did/are doing in early and late development in assigned therapeutic areas.
Proficient understanding of chemistry and biology relevant to therapeutic area.
Understanding the impact of new laws, regulations, guidance, and rulings on drug development (ability to incorporate this into the regulatory functional/strategic plan).
Ability to effectively communicate with project/product teams; liaise with data generating departments and Health Authorities as required
- HA Interactions
Understanding of procedures for working with HA's.
Understanding procedures for approaching, influencing HA's.
Knowledge of history of positions HA's have taken on particular issues.
Knowledge of HA procedures that need to be followed.
Understanding how a HA perceives, handles and provides feedback to submissions.
Understanding of individual HA review practices.
- Technical expertise
Respected and consulted by peers for technical knowledge
Understand drug development and lifecycle management
Understand scientific principles for the manufacture of the drug substance and drug product
Knowledge of the content/data necessary to prepare CMC sections for regulatory submissions
Decision-making and Problem-solving:
- Develops and executes the CMC regulatory strategy for product(s) or CMC variation(s)
- Uses an innovative and systematic approach to solving problems
- Support CMC RA Head to work with RA product owners to manage and resolve any “CMC issues”
- Independently reviews submissions
- Formulate recommendations on critical regulatory issues
- Aligns and gains agreement of CMC RA position with therapeutic area regulatory leadership to ensure regulatory strategy is aligned with therapeutic area goals and local/global regulatory strategy
- Works within established priorities to meet Business Unit and functional goals and objectives, while seeking guidance to resolve conflicts.
Responsibility for Others:
- Appreciates, values and recognizes each person in the organization
- Participates on cross-functional teams
- Contributes to training of RA personnel as needed
- Interact with professional colleagues – Janssen China RA colleagues, CMC RA colleagues, CMC team members, therapeutic area leaders, and external partners GRA management as project and functional objectives and needs dictate
- Support CMC RA Head to conduct due diligence /licensing evaluations when necessary
- Participates in cross-functional teams to manage and resolve any “CMC issues”
- BS required with 5+ years of experience, MS with 3+ years of experience or Ph.D. with 2+ years of experience.
- Demonstrated ability to communicate regulatory requirements.
- Fluent in English, both written and oral.
- High-level verbal and written communication skills.
- Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to corporate project teams.
- Demonstrates model behavior that understands what the priorities are and encourages others to drive for results
- Experience leading interactions with health authorities
- Strong knowledge of local and global HA laws, regulations, guidance and global regulation submission routes available for new study drugs
- Detailed understanding of competitors in the area and what they are doing in early/late development
- Solid understanding of chemistry. Training in analytical chemistry, pharmaceutics or other relevant subjects are highly desired.
- Experience developing regulatory strategies and seen as an expert on product development and how it is applied.