Sr Director, Regulatory Affairs
Sr Director, Regulatory Affairs
China - Beijing
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
SENIOR DIRECTOR, REGULATORY AFFAIRS, CHINA
Provides leadership, direction and coordinates local regulatory activities to enable the development, registration and life-cycle maintenance of Gilead's innovative therapeutics that address unmet medical needs and improve patient care. Responsible for working with local Regulatory Authorities and both global and local teams within Gilead to ensure that the company complies with all applicable local legislations, regulations and guidance in the development and execution of the local regulatory strategy.
Essential Duties and ResponsibilitiesCore Technical Regulatory Contributions
Interaction with Local Health Authorities (HA)
- Lead the interaction and communication with the local HAs and act as the main point of contact for the local HAs. This includes (not exhaustive):
- Works proactively to build and maintain contacts with relevant local HA personnel, including Central and Provincial NMPA
- Lead interactions with other departments/functions for response to local HAs
- Consultation meeting and Panel meeting preparation and follow-up
- Management of relevant local HA inspections
- Quality defects / falsified or counterfeit products / batch recall management
- Out of stock situation management
- Management of, or support for incidents involving regulatory matters (as required)
- Dear Healthcare Provider Communications submissions and follow-up until approval.
- Risk Assessment Report or Risk Minimization Measures submissions and follow-up until approval, as required and applicable
- Liaison and facilitate Specification Drug Test by the National Institute of Food and Drug Control (NIFDC) or its designated testing bureau
- Chinese Pharmacopeia Commission on drug specifications in Chinese Pharmacopeia as needed
Ensure that all regulatory submissions to local HAs are done in line with local HA requirements, Gilead SOPs and business objectives for assigned product(s) and country.
Main types of submissions are (not-exhaustive):
- Clinical trials applications, amendments and other clinical trials submissions
- New Drug Applications (NDA) or Import Drug Licenses applications
- Supplemental NDA applications
- Post-marketing variations to maintain Import Drug Licenses
- Risk Assessment Report or Risk Minimization Activities materials, as required
- Dear Health Care Professional communication
- Promotional materials, as required
- Adverse Events Reports per regulatory requirements and GLPS corporate requirements
- Relevant applications as needed to support locally-manufacturing plan & activities such as Product Production Permit Application, GMP, Bulk Import Drug License Application for Repack activities
Local Statutory Responsibilities and Liabilities
Ensure that Gilead fulfills all requirements linked to the Marketing Authorization/ local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder.
Act as the local Gilead representative as required by national law.
Examples: Act as local representative: Qualified Person, Responsible Person / Pharmacist, Local Qualified Scientific Service Person or Technical Responsible.
Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead
- Ensure compliance with local law and regulation and consistency with global procedural documents
- Lead the creation, maintenance, training, evaluation and tracking of all local regulatory owned procedural documents including policies, SOPs, manuals and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in the scope of GMP/GDP, GPvP and GCP
- Manage Regulatory Compliance audit within affiliate and assure that the General Manager and other departments are aware and support the process
- Maintain GDP license in the country, as required and set up internal and 3PL audits management as appropriate
- Ensure the establishment of Quality Agreements where required
- Ensure Promotional material review and approval, submission to HA if applicable
- Ensure compliant labeling for Gilead medicinal products in the country (prescribing information, packaging) and manage timely updates
Input into Development
- Provide input to the global regulatory product strategy as appropriate.
- Share with US/Global/development teams/Pharmaceutical Development Manufacturing (PDM) knowledge on:
- HA expertise, expectations and requirements
- National scientific advice relevance and requirements
- Regulatory Authority contact profiling
- Manage negotiations with local HAs with regards to development products and local manufacturing plan (e.g. questions on clinical trial applications)
Closely monitor and communicate all external relevant changes to concerned stakeholders within the company at local and global level.
Monitor competitor regulatory information such as approvals, changes in label and other relevant local details. If applicable, Regulatory Affairs (RA) contributes to relevant local guidelines and regulations' development that impact Gilead, identifying trends and changes that may impact on the company.
Anticipates potential challenges in registration and changes in health care policies that could impact Gilead and develop strategies to optimize the outcome.
- Maintains up to date knowledge of highly complex regulatory requirements, contributes to preparation of new local regulatory guidance when applicable, comments on draft regulatory guidance and communicates changes in regulatory information to US/Global RA teams
- May participate in local industry trade groups and regulatory affairs professional societiesManagement and Leadership
Provide the Vision and Direction for the RA organization at the country level in line with global regulatory strategy, objectives of the Therapeutic Areas within R&D, and Gilead Core Values.
- Serves as a core member of the country leadership team as the representative of Regulatory Affairs
- Leads the country regulatory team and communicates with the US/Global regulatory teams
- Sets clear goals and objectives in line with the global RA strategy
- Actively participates in internal and external working groups
- Leads and/or represent RA within cross-functional and/or cross-regional regulatory sub-teams
- Plan, monitor, allocate and optimize resources and budget with regards to portfolio evolution as well as regulatory changes
- Ensure a sufficiently staffed and adequately trained RA department
- Develop local RA team with clear succession plans for critical roles
Key Differentiating Responsibilities / Contributions
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in local legislation or regulatory guidelines
- Ensure optimum execution of RA registration strategies and coordinates activities with cross-functional representatives in the country
- Establishes and maintains good and strong relationships with all functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc) and with Gilead Sciences US/Global RA
- Takes a leadership role in conducting risk assessments on major local regulatory issues
- Take the leadership role in updating and preparing the Company for major changes in regulatory legislation in the country
- Decision Making: Makes important decisions that impact the department and ensure appropriate communication
- Plays an active role in industry organizations building recognition as a thought leader, as required locally if appropriate.
- Initiates or contributes to local and / or global process improvements which have a significant impact on Gilead.
- Represents Regulatory Function at internal meetings
Professional Experience / Key Skills
- Typically requires a PhD or Masters in Pharmaceutical Sciences or equivalent discipline and minimum 10 years of relevant experience in regulatory affairs.
- Extensive experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Biotech Industry including international requirements, e.g. ICH requirements and national requirements, e.g. NMPA requirements etc. and have an understanding of current trends
- Strong influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with senior representatives in local Regulatory Authorities
- Demonstrates strong leadership skills with a sphere of influence externally, cross-functionally and within the RA function and in the affiliate
- Previous people management experience is required and direct experience working with Regulatory Authorities essential
- Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
- Excellent verbal, written, organization skills and interpersonal communication skills
- RA //ICHNMPA
- For Current Gilead Employees and Contractors:
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