Regulatory Affairs Manager/Senior Manager/Associate Director/Director
1. Responsible for overall regulatory strategy & timeline, developing optimal registration strategy for projects.
2. Responsible for the preparation and validation of registration dossiers; ensure the dossiers are in compliance with health authority regulation and their timely submission and approval.
3. Ensure timely, clear communications on project regulatory status/issues/risks with management, and with health authorities as appropriate.
4. Develop and implement internal processes and system to support regulatory submissions and approvals.
5. Maintain up-to-date knowledge and expertise of relevant guidelines and regulations.
1. Bachelor or above degree in Life Sciences, Pharmacy or Medicine.
2. At least 5 years of regulatory affairs experience in pharmaceutical industry. Prior global regulatory experience in development is preferred. Prior oncology product experience is preferred.
3. In-depth knowledge of regulatory environment, regulations & guidelines.
4. Proficiency in English (oral and written).
VP, Biology will work with the management team to provide scientific leadership at the Company. This person will lead a team of scientists to progress breakthrough therapeutic agents from discovery to the clinic. The successful candidate will have a strong entrepreneurial spirit and leadership and team-building skills. The position reports to SVP, Research and can be based in Jiaxing, China or Burlingame, California (US).
1.Provide scientific vision and strategic input in developing R&D approaches for oncology initiatives.
2.Provide subject matter expertise for incorporating the latest scientific discoveries, methodologies, and technologies in the oncology field that can impact internal projects.
3.Efficiently integrate internal and external CRO resources to advance drug discovery programs.
4.Deliver high quality lead candidates for clinical development.
5.Participate in the creation of IP portfolio.
6.Provide critical input in developing translational approaches to bring new agents through the clinic.
7.Actively engage with Company’s scientific advisors and collaborators.
8.Build and maintain good working relationships with key opinion leaders and principal investigators.
9.Contribute to the preparation of documents, as needed, to support regulatory filings.
10.Establish a culture that promotes creativity, open communication, collaboration, collegiality, and a sense of urgency while maintaining the highest standards of scientific rigor.
11.Recruit, motivate, retain, and develop people in the Biology department.
1.Ph.D. and/or M.D. in cancer biology or related fields.
2.At least 15 years of relevant industry experience in the oncology field.
3.A consistent track record of scientific excellence as reflected by high impact, peer reviewed publications and patents.
4.A thorough understanding of scientific, commercial, regulatory, ethical, and legal aspects of drug discovery.
5.Strong leadership and verbal communication skills.
6.The ability to thrive in a biotech environment.
Clinical Pharmacology Director/Manager
1. Serve as a program level clinical pharmacology lead and a PK/PD content expert and has a broad range of responsibilities that include developing and prioritizing strategic, tactical, and participation in multiple matrixed research and development teams.
2. Contribute to early development and clin pharm strategy, as well as the planning and implementation the appropriateness of study designs, and generate high quality of data, adherence to Good Clinical Practices to meet both domestic and international requirements.
3. Contribute to the preparation of submission documents to health authorities.
4. Work with cross-functional team to establish project success criteria, monitoring project progress, and communicating information to management.
5. Ensuring that clinical pharmacology requirements are understood and incorporated upfront from product concept development. This helps ensure that products are developed in a way that will facilitate prompt regulatory approvals with competitive advantages in the intended markets.
6. Participate in assessing new product opportunities and identifying requirements for projects under consideration, including evaluation of clinical pharmacology and clinical efficacy data owned by external organizations with regard to potential product acquisitions or partnering in product development.
1. Ph.D. in Pharmacology or PharmD with a minimum of 5 years of industry experience is required.
2. Prior experience in oncology drug development and interactions with regulatory authorities is preferred.
3. Knowledge in drug metabolism, pharmacokinetics, pharmacodynamics, clinical trial design, and regulatory requirements for drug development is required.
4. The ability to work in a matrix environment with global/local cross-functional teams is essential.
5. Excellent communication skills, self-motivated, innovative, with highest level of professional ethics, accountability.
6. Proficient in English (oral and written).