Our client is one of the world's leading supportive cancer care companies with a comprehensive portfolio of medicines and therapies helping to improve the lives of patients in countries around the world.
Duties and Responsibilities:
The Head of Regulatory Affairs provides regulatory expertise and leadership in the discussion and implementation of regulatory strategies directly and/or in collaboration with HQ and external parties, for the effective regulatory development, approval and maintenance the products in China:
- Provide regulatory guidance and input on drug development and regulatory strategies in close collaboration with Group RA within the appropriate platform/team. Develop registration scenarios, budgets and timelines, estimate risks in order to optimize the regulatory
- Be responsible for the regulatory submissions of new drug, variations, renewals, clinical trial applications and other regulatory application in relation to pipeline or marketed products in
- Collaborate closely with Group RA, manage local CROs and consultants for the successful preparation and submission of documentation to the Health Authority, including the preparation of replies to deficiency letters and ensure the data requirements are submitted to regulatory agencies within the stipulated or agreed
- Ensure that Group RA are kept fully informed on the current regulatory status and feedback from regulatory authorities of the assigned products and on the feedback from the business partners
- Be accountable for communicating with regulatory authorities to properly address product related questions and coordinating and leading meetings.
- Maintain up to date knowledge of the relevant regulation of China and provide assessments of the impact of new and changing regulations on the company's portfolio of
- Establish and maintain good working relationships with regulatory authorities (NMPA, CDE, Institute for drug control, ) to ensure regulatory compliance and timely product approvals.
- Provide support during GCP and GMP (CFDI) Help to promptly coordinate internal resources and provide regulatory feedback.
- Liaise with the regulatory counterparts of Helsinn’s business partners to provide product regulatory
- Responsible for the development of local departmental SOPs and ensuring adherence.
- Develop and oversee the department budget.
- Minimum 10+ years of managerial experience in Regulatory Affairs roles, with Oncology and/or Cancer Supportive Care experience being a Candidates with fewer years of managerial experience but with outstanding achievements and abilities will also be considered.
- B.S. or above in Pharmacy, Medical, Biology or related field
- Self-motivated, with an entrepreneurial spirit, hands-on and objective-oriented person, with a demonstrated track record of achievements
- Excellent communication and interpersonal/network building skills
- Availability to travel in China as well as occasionally
- Mandarin native speaker; Fluency in both written and spoken English
Qualified and interested Parties please apply with your CV and latest salary in Word format to email@example.com