赛默飞世尔科技（中国）有限公司新闻资讯

JOB SUMMARY:

Establish and strengthen site regulatory expertise & capability to support biological drug substance and drug product CDMO business.

• Provide expertise in NMPA’s IND/BLA submission pathway and regulatory requirements for biological products at various developmental & commercial stages in supporting the creation of CTD M3-Quality/CMC business proposals and Clients in their submissions’ journey.
• Liaise with global regulatory experts to address Clients’ ambition to submit IND/BLA primarily in China and also in other main jurisdictions (USA, EU).
• Keep abreast of the evolution of Chinese specific regulatory changes, develop intelligence in industry approaches and compliance trends to maintain site agility in regulatory front.
• Manage interfaces with key Network sites, Clients & Regulatory Agencies to develop and execute regulatory strategies.

RESPONSIBILITIES:

Regulatory Services:

• Assist in quotations preparation and enable quick proposal with clear regulatory input for Clients at different stages:

• Establish site regulatory strategy and guidance/procedures as per NMPA/FDA/EMA biologics regulations pertaining to INDA/BLA/MAA;
• Evaluate regulatory feasibility and provide insight to potential clients screening;
• Provide specific state of the art regulatory pathway and spell out necessary regulatory deliverables for detailed proposal to enable competitive quotations for Clients with different needs through product life-cycle from R&D, pre-clinial, clinical to commercial and post approval changes.

• Promote CTD M3-Quality/CMC regulatory services offering and associated revenue generation:

• Act as a facilitator with Clients for complex regulatory solving problems;
• Deliver ad hoc expertise on registration files relevant to clinical and/or commercial applications and assess overall regulatory acceptance/risk and generate CMC/Quality deliverables;
• Contribute to registration files authoring & review for on-time delivery;
• Report regulatory services metrics per regional schedule.

Regulatory Intelligence:

• Monitor, anticipate, pre-evaluate and communicate on major pharmaceutical regulations impacting the Biological Drug Substance and Drug Product aseptic manufacturing business:

• Participate pro-actively to industry working groups to anticipate regulations development and facilitate implementation;
• Provide SME consultation to organization.

• Ensure domestic regulatory knowledge enhancement:

• Enable regulatory updates visibility to organization in a timely manner by disseminating information via adequate means;
• Develop appropriate forums & tangible trainings to key stakeholders (Quality, BD etc.).

Regulatory Compliance:

• Establish and maintain the regulatory compliance systems and serve as regulatory gateway for site between external and internal regulatory interactions:

• Site compliance:

• Set-up & maintain relevant data base to capture site licensing material (SMF +/- foreign accreditations inclusive);
• Build seamless connection with QA Compliance team for site compliance related regulatory update, to enable QA Compliance team to do gap analysis and/or comments feedback.

• Product compliance:

• Set-up & maintain Clients’ CMC files data base to ensure compliance with production and control master documents and enable product related regulatory gap analysis and or comments feedback;
• Provide regulatory input on Change Controls initiated by the site or the Clients, and input on relevant deviation investigation as well.

• Be the point of contact with external regulatory parties/agencies for new regulatory requirements comments feedback and any consultation for regulatory interpretation;

• Sponsor Regulatory Compliance optimizations relevant to site and product conformance:

• Develop and/or executive regulatory compliance initiatives: define work plan to fulfill the gaps, follow-up on implementation, sustain life-cycle management activities;
• Establish local regulatory compliance indicators and report performance within set regional schedule.

REQUIREMENT

Education:

• At least Bachelor’s degree in Life Science (ex: Pharmacy, Chemistry, Microbiology).

Experience:

• Minimum 10 years of directly relevant pharmaceutical regulatory affairs in the biological space, and cGMP manufacturing operational exposure (sterile environment).
• Familiar with Biologics Regulatory techniques throughout the whole product life cycle, CMC development, pre-clinical to commercial etc.

Competencies:

• Intimate knowledge of China, USA, EU regulatory landscape (including GMP essentials) and exposure to professional communities such as RDPAC etc.
• Advanced ability to evaluate and resolve complex regulatory and technical issues
• Ability to demonstrate discretion, confidentiality and independent judgement
• Advanced negotiation and influencing skills with relevant partners, internally-externally Collaborative team player with strong interpersonal skills who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, internal (Quality/EHS/Business/Sales/Legal …) and external (Regulatory Agencies, Clients)
• Advanced organizational skills, with ability to multi-task in a fast-paced environment and effective time management and prioritization skills.
• Results-oriented self-starter who can execute roles and responsibilities with remote supervision
• Effective verbal and written communication skills
• Sound skills in typical office electronic platforms and IT agility

Languages:

• Chinese and English