Auto req 12927BR
Job Posting Title Director Regulatory Affairs (China)
Career Category Regulatory
Employee Subgroup Salaried FT
Country (State/Region) China
Location (City) Beijing
Amgen Job Description This is an opportunity for a Director position as head of Global Regulatory Affairs and Safety (GRAAS) -China. This senior position will be the primary point of interaction with the local regulatory agency to obtain and maintain local regulatory commercial and clinical trials approvals. The individual will develop suitable regulatory and quality standards around which others will operate; provide Regulatory expertise to all projects which need to follow national regulations/guidelines. Will build and lead the country regulatory function and ensure all Business and R&D Compliance standards (internal and external) are adhered to.
Key responsibilities include:
- Being the primary point of contact for regulatory authority (ies) in China.
- Obtaining and maintaining local product and pharmaceutical company licenses.
- Senior contact point for any regulatory advice for commercial and medical projects within country/sub-region.
- Translates global and international business plans to local regulatory and quality objectives
- Representing Compliance and Regulatory on the management team of a large country/sub-region
- Ensuring that local processes, strategies and initiatives are aligned with regulatory requirements defined by Amgen International and Global groups.
- Overseeing the affiliate compliance framework to comply with Local Code & legislation & Amgen Policies and procedures
- Identifying the need for country specific compliance procedures and overseeing their development and implementation
- Providing senior level regulatory expertise into International regulatory affairs group.
- Ensuring local implementation of key regulatory projects communicated from the International Regulatory Affairs department
- Expertise in national implementation of Chinese DL and regulatory
- Collaborating with the local affiliate Medical Director to establish registration strategy, local regulatory affairs processes and planning for clinical studies in accordance with national legal and regulatory requirements.
- Developing, implementing and maintaining local processes and procedures to meet Regulatory and Quality components of local legislation (advertising and promotion, product recall, product complaint handling, internal and external audits, product release)
- Manage regulatory and quality inspections from the SFDA.
- Provide regulatory advice around early access programs and other medical needs .
- Independent management of regulatory team including recruiting, selecting, supervising, training, mentoring and developing regulatory affairs staff.
- Participates in local industry and trade association groups relating to Amgen business activities and the profession of Regulatory Affairs.
- Approve promotion & advertising material to be used by LOC Commercial Organization
- Approve scientific (non-promotion) material to be used by LOC Medical Affairs
- Provide advice, guidance and support to office and field based staff on interpretation and implementation of the Local Code & legislation and Amgen policies & procedures
- Act as primary contact for customer-related compliance enquiries
- Support the monitoring, auditing and self assessment activities that take place under the Compliance framework
- Monitor changes in the local Trade Association Code & national legislation and forward relevant information to local and regional groups
- Coordinate roll out of Corporate Compliance initiatives and local compliance trainings with relevant internal groups.
Basic Qualifications - Doctorate degree & 4 years of directly related experience
OR
- Masters degree & 8 years of directly related years
OR
- Bachelors degree & 10 years of directly related experience
Preferred Qualifications - Regulatory Affairs background providing technical, strategic and/or managerial support for the
creation, review, and finalization of components of CTA and/or Marketing Applications
and regulatory submissions. Leading local regulatory policy initiatives.
