长沙招聘

Summary:

We are seeking a highly motivated individual with strong technical background in the field of therapeutic antibody drug development, regulatory writing experience for submission (IND and BLA in CTD format) of supporting documents, which are focused on either CMC (Chemistry, Manufacturing, and Controls), or nonclinical pharmacology, pharmacokinetics, toxicology, or clinical efficacy and safety studies. The successful candidate will serve as the lead writer for regulatory filings, will manage and execute the end to end process of delivering these documents across the functional departments.

Responsibilities:

• Write, edit, review and manage the internal report development process to deliver technical reports for INDs, BLAs, MAAs, and associated regulatory submissions.
• Collaborate closely R&D functional teams to ensure production of consistent, accurate, high-quality technical reports meeting regulatory requirements.
• Perform literature searches as needed and summarize data for incorporation into documents.
• Streamline, maintain and execute the end to end process for coordination of authoring, editing, reviewing, verifying and approving regulated technical reports.
• Responsible for tracking all report deliverables for programs in scope.
• Provide training to staff on the process of regulated technical reports as needed.
• Write, revise and edit departmental SOPs as needed.
• Performs other tasks as directed by the line manager.

Requirements:

• Advanced degree in life sciences preferred; 2 years+ of industry experience in regulatory writing.
• Strong technical background in the field of antibody drug development is a plus.
• Knowledge of FDA, EMA and NMPA regulations and ICH guidance.
• Demonstrated writing skills with strong command of bilingual (English and Chinese) language and grammar.
• Must possess excellent interpersonal, organizational, written and verbal communication skills along with ability to work collaboratively in a team environment.
• Efficient, organized, and able to handle short timelines in a fast-paced, dynamic environment.
• Proficient with document management software/systems, such as filing systems and ELN.
• Prior supervisory experience preferred.

百奥泰生物制药股份有限公司（股票代码：688177）秉承“创新只为生命”的理念，致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病以及其它危及人类生命或健康的重大疾病。公司已推动五款候选药物进入后期临床试验，其中格乐立（阿达木单抗）已在中国获批用于治疗类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病和葡萄膜炎。此外，公司另有多款主攻肿瘤和自身免疫性疾病的候选药物处于不同的临床开发阶段。公司始终以患者的福祉作为首要核心价值，通过创新研发为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问公司官网或关注我们的微信公众号“百奥泰”。
Bio-Thera？Solutions, Ltd.a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials, one of which, QLETLI, a biosimilar to？Humira？(adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis,？Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.