Head of Regulatory
Zhejiang Hisun Pharmaceutical Co. Ltd. was established in 1956 and currently employs over 10,000 people. It is a public trade company (stock code 600267) listed in Shanghai Stock Exchange. Hisun focuses on the integration of pharmaceutical research and development (R&D) with manufacturing capabilities to provide its global customers with outstanding products and services. To date, over 100 of the company's products have passed inspections by the FDA (U.S.), EDQM (EU), TGA (Australia), KFDA(Korea), etc., and are sold in more than 70 countries worldwide.
Hisun Pharmaceuticals USA, Inc. was established in USA in 2009 and is a wholly owned subsidiary of Zhejiang Hisun Pharmaceutical Co. Ltd. We are dedicated to the global expansion of Hisun company. Our team is comprised of industry experts in Business Development, Marketing and Sales, Regulatory, Quality Assurance to support our international customers. Currently we have a Regulatory/portfolio strategist position open in our Bridgewater, NJ Office.
Head of Regulatory
Hisun USA has an exciting opportunity for an experienced regulatory/portfolio- strategy professional in our Bridgewater, NJ office. This position is at Manager/Director level based on experience, who will directly report to the CEO of Hisun USA.
- Lead the strategy of commercial product selection based on in-depth awareness of regulatory requirements and market intelligence
- Evaluate both internal and external products to build a sustainable product pipeline for commercialization
- Perform market analysis of products of interest, come up with appropriate business models, and make recommendations
- Identify and interact with partners for potential collaborations
- Assist with development and maintain standard market evaluation procedures with continuous optimization
- Implement regulatory policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- Oversight for the DSCSA regulation policy and its implementation
- A scientific degree, either BA/MS/Ph.D. in pharmaceutical science, biological sciences, or chemistry disciplines is highly desired
- Minimum 3+ years of regulatory and portfolio evaluation experience within a biotech/pharmaceutical environment
- Rich knowledge and experience in international registration and regulation
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Demonstrated leadership capability and an ability to manage priorities and work under tight timelines
- Marketing analysis experience or know-how
- Bilingual ability in English/Chinese preferred
As a member of the Hisun Pharmaceuticals USA team, you’ll find an environment that celebrates diversity and encourages the open exchange of ideas. We are proud to offer an attractive salary along with a generous benefits package including employer matched 401(K) program, paid vacation days, medical, dental, vision, and life insurance packages.
Interested candidates should submit their resumes to email@example.com