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Manager, CMC Regulatory Affaris
Requisition ID: 1805633141W
The primary responsibility of the CMC Regulatory Affairs Sr. Manager is to provide CMC RA supports for the submissions in China with a current focus on a CAR-T CTA submission in 2018. He/she will also support chemical and biological product filings across multiple registration categories in China. He/she will be involved in communication with global CMC RA and PDMS 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 RA CMC RA Director to build a closer connection with CFDA and influence the local regulatory environment. He/she will participate in RDPAC task forces and activities and comment on CFDA 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 CFDA.
CMC RA Manager:
Provide supports to CMC RA activities that include development of submission CMC strategy and support preparation of CMC dossiers in compliance with Chines 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 Director
Participate in technical and regulatory discussions for preparation of regulatory CMC dossiers for submission to CFDA
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
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 CFDA and PFDA as needed
Communicate with global CMC RA to ensure the development strategies are consistent with evolving expectations of CFDA
Support development of CMC regulatory strategy for CTA and NDA/BLA 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 CFDA to support CTA and NDA/BLA 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 CFDA or Shaanxi PFDA and provide strategy as issues arise to gain rapid approval with reasonable risk
Support CMC RA Director to work with CMC RA and PDMS DDO to develop and maintain CMC dossier for CTA and NDA/BLA 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 CFDA or PFDA
Ability to negotiate with HA personnel on CMC strategy, content requirement, and QC testing challenges
Support preparation of responses to CFDA or PFDA questions (ensure alignment with local /global strategy)
Effectively and tactfully communicate with CFDA and PFDA; maintain good rapport and credibility with the Agencies
Actively influence the future CMC regulatory environment through direct interaction with CFDA 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 CFDA 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:
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
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.
• 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
J&J (China) Investments Ltd (7046)