VP Global Regulatory Affairs

Location
Washington, DC area or Guangzhou, China
Posted
Jun 08, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Description:

This senior level position supports Bio-Thera decision-making and product R&D by leading the company’s global regulatory activities. We are seeking an experienced, motivated individual to serve as our regulatory officer responsible for managing, developing, and implementing strategies for the company’s global drug applications. The position can be based in US, and report to the CEO remotely. She or he will join the company’s senior leadership group.

Major Responsibilities:

Works with project teams and department leadership team to develop regulatory strategies, identify regulatory risks, and enable regulatory approval as quickly as the data and regulations allow;

Lead regulatory communications with regulatory agencies. Prepare briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, BLA, INDs, Safety and Annual reports, and communicate with and responses to regulatory agencies about regulatory issues.

Ensure all nonclinical and clinical regulatory programs such as pharmacology, toxicology, and clinical trials are appropriately structured to meet US, EMA, and other regulatory requirements.

Ensure all the manufacturing and quality programs such as process and manufacturing development, validation plans, and labeling, relevant to the chemistry, manufacturing and controls of pharmaceutical products are appropriately structured to meet US, EMA, and other regulatory requirements.

Lead and manage preparations of regulatory submissions, so that complete, cohesive and professionally prepared documents (NDAs, BLAs, INDs, CTAs, amendments, notifications, and other reports) are in place according to global regulatory guidelines;

Qualifications:

Advanced degree in regulatory science, life sciences, with 10+ years in a senior management role in the biotechnology and/or pharmaceutical industries.

Solid experience in bringing biologics to BLA/MAA submission phase and commercialization in major markets.

Extensive experience in communicating with agencies in areas such as clinical development plan, pivotal trial endpoints, and country-specific strategies relative with national authorities; proven ability to provide regulatory leadership and expertise within a cross-functional, team-based environment.

Excellent written and verbal communication skills; demonstrated ability to build relationships and act as liaison with regulatory agencies on drug development matters;  extensive regulatory background with demonstrated ability to work with the FDA, EMA, and other health authorities worldwide.

Hard working, driven to achieve creative and sound results; previous experience with leadership, collaboration, teamwork, and proven track record of success in obtaining regulatory approval in a major market in product areas of oncology, autoimmune or related areas is a plus.

Experience in working effectively in multicultural environments is a plus.  The company is headquartered in Guangzhou, China, and the position is full-time and can be based primarily in Guangzhou, or US. International travel is required. Bio-Thera provides competitive compensation package including company stock.
 

About BIO-THERA: 
Bio-Thera Solutions Ltd ( www.bio-thera.com ), an emerging biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancers, autoimmune, cardiovascular diseases, and other life threatening conditions. The Company's initial internal products were focused on validated targets and disease areas with proven market opportunities. Two of our advanced programs, BAT2094 for coronary heart diseases and BAT1406, an adalimumab biosimilar, have competed Ph 3 and NDA/BLA will be submitted to CFDA in 2018. The company product pipeline in clinical stage includes biosimilars and innovative antibodies, with three of the biosimilars in clinical for global development (bevacizumab biosimilar, adalimumab biosimilar, and tocilizumab biosimilar).  Two other programs are in late clinical stages, BAT8001 (anti-Her2 ADC) and BAT1306 (anti-PD-1 antibody) for cancer treatment.  The company has multiple candidates in research, IND-enabling preclinical stages, and early stage clinical with focusing on innovative targets in the immune checkpoints and autoimmune diseases.  A new cGMP facility in compliance with ICH-cGMP (EMA and FDA regulations) has been built for the production of commercial therapeutic antibodies in Guangzhou, and new company headquarters with R&D center is being built in Bio-Island, Guangzhou.  The company has a R&D team of over 300 scientists and engineers, including many trained in the US.  The Company is also looking for senior level scientists, engineers, and executives in the areas of biomanufacturing sciences, process development, quality assurance and management, and clinical science. The company is also sincere and zealous in search and commitment to partnerships.  Please contact bd@bio-thera.com if there is interest in exploring potential R&D or commercial collaboration. To learn more about Bio-Thera, please visit www.bio-thera.com.  Bio-Thera is an equal opportunity employer.