德资药企招聘法规事务高级经理

吴红岩医药荐客 2022-01-04

This company focus on radioisotope production and the application of radiotheragnostics to its developing oncology pipeline.

The Senior Regulatory Affairs Manager will work closely with Global Regulatory team to support China clinical development activities and develop regulatory strategies and prepare and/or review regulatory documents leading to CDE filing and approval of NDA/ MAA of key asset molecules, as well as INDs/CTAs for pipeline candidates in earlier stage of clinical development.

The Senior Regulatory Affairs Manager China will work closely with external sub-contractors (CROs) and interact with various internal departments (Medical, Clinical Development and Operations, CMC and Commercial).

Key responsibilities

Align with global development strategies, develop and implement China-specific regulatory strategies for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies.
Collaborate with external contractors and consultants in the execution of the regulatory activities.
Write and/or review of regulatory documents required for filing of NDA/MAAs and IND/CTAs, including but not limited to CTD modules, Product Information, responses to the CDE questions, clinical study protocols and reports, investigator’s brochures, case report forms, informed consent forms and other relevant documents.
Prepare and/or review briefing documents for CDE meetings.
Contribute to regulatory due diligence of the existing preclinical, clinical and CMC data from EU/US region in support of market expansion to China.
Monitor changes in the regulatory environments and advise on company adaptive responses.

Background and Experience

Life science degree, a master degree or equivalent is preferred
Proficiency and fluency in English (written and oral).
7+ years of regulatory and drug/biologic development experience, ideally in oncology indication. Experience with diagnostic radiopharmaceuticals will be an asset.
Preparation of regulatory dossiers and submissions to CDE.
Regulatory writing.
Proven success in China drug regulatory submissions.
Leading the regulatory activities from early development to commercial launch.
Good preclinical and clinical data interpretation/data analysis skills.
Good management, interpersonal, communication, negotiation and problem solving skills.