【Sr Manager, Regulatory Affairs招聘】_2024北京Sr Manager, Regulatory Affairs招聘信息-猎聘

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职位介绍: Primary Function: • Be accountable for developing regulatory strategy for the responsible projects with the guidance of senior regulatory manager • Be accountable for the regulatory strategy implementation by CTA/NDA submission/approval • Be accountable for HA interaction for regulatory strategy assessment with the guidance of senior regulatory manager • Support line manager for regulatory intelligence collection and analysis • Support line manager on integration for regulatory strategy assessment Major Responsibilities and Duties: 1. Responsibilities • Adherence to Zailab and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.  Align with the values and vision of Zailab  Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, Zailab code of conduct  Maintain company confidentiality (i.e. intellectual property, product information and strategic information)  Disclose potential breach of codes or conduct  Follow SOP requirements especially on documentation • For allocated portfolio develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.  Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy  Assist in ensuring local regulatory strategies are consistent with global product strategies and local priorities  Develop regulatory plan in conjunction with key stakeholders, ensure allocation of adequate resources and deliver plans on time  Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch • Maintain product licenses in assigned portfolio through timely renewal to a high standard.  Monitor status of product licenses  Project manage changes in product licenses and coordinate with other changes, planned and in progress  Maintain complete documentation records  Communicate changes to license status promptly • Maintain the awareness and shape the regulatory environment relevant to the assigned portfolio.  Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products  Communicate the impact of changes to key stakeholders.  Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes • Actively develop excellent relationship with local regulatory authorities and external stakeholders.  Build up Zailab’s good image through high professional standard of application, response to enquiries etc.  Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings • Drive issue Management.  Provide detailed analysis on regulatory status of affected products  Develop and undertake assigned follow-up action where necessary 2. Marketing Support • Attend Regulatory Affairs, Clinical Operation & Regulatory and other internal meetings as required 3. Teamwork Spirit • Actively participate in team working • Share best practice examples & learning with the team and regional/global colleagues 4. Personal Development • Attend and actively participate in personal development courses as required • Participate in Regulatory Affairs and Clinical Operation & Regulatory related workshops Qualifications: o Education, Qualifications  Bachelor or above in Pharmacy, Medical, Biology or related field o Skills  Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.  Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.  Project management primary level skill  Chinese and English (proficiency level)  Computer skill: word, excel, power point o Experience  At least 7 years’ experience in below positions.  Good track record; independent working; experience in drug/biologic manufacturing is a plus

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