Zhejiang Hisun Pharmaceutical Co. Ltd. was established in 1956 and currently employs over 9000 people. It is a public trade company (stock code 600267) listed in Shanghai Stock Exchange. Hisun’s vision is to become a well-respected international pharmaceutical company by advancing its mission of persisting in pharmaceutical innovation for the benefit of human beings. Hisun focuses on the integration of pharmaceutical research and development (R&D) with manufacturing capabilities in order to provide its global customers with outstanding products and services. To date, over 70 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 40 countries worldwide.
Hisun Pharmaceuticals USA, Inc. was established in New Jersey in November 2009 and is a wholly owned subsidiary of Zhejiang Hisun Pharmaceutical Co. Ltd. We are dedicated to the global expansion of Hisun Pharmaceuticals. Our team is comprised of industry experts in Clinical Research, Business Development, Regulatory, Marketing and Supply Chain supporting our American customers. Currently we have several openings in Regulatory, Generic Drug Sales, and Business Development areas in our Bridgewater, NJ Office.
Regulatory Manager (CRM)
Hisun USA has an exciting opportunity for an experienced regulatory professional in our Bridgewater, NJ office. The position is Regulatory Manager/Senior Manager/Associate Director/Director based on experiences, who will directly report the CEO of Hisun USA.
- Act as liaison between Hisun USA and Hisun Headquarters for all the regulatory affair matters in front of FDA and other countries’ regulatory authorities
- Provide responses to regulatory agencies regarding product information or issues.
- Train staff in regulatory policies or procedures.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop and maintain standard operating procedures
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Participate in the development or implementation of clinical trial protocols.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability
- Monitor regulatory affairs trends that are related to environmental issues.
- A scientific degree, either BA/MS/Ph.D. in pharmaceutical science, or biological sciences/chemistry related disciplines is required
- Minimum 5+ years of regulatory experience within a biotech/pharmaceutical environment.
- Prior experience and successful completion of BLA and/or NDAs and MAA application(s) is preferred.
- Prior experiences in generic pharmaceutical industry is a plus, especially with experiences in biosimilar regulations.
- Direct experience interfacing with relevant regulatory authorities.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Ability to interpret compliance requirements for the creation or review of protocols and site documentation
- Global CMC Regulatory experience desired: US, Canada, EU and Japan.
- Demonstrated leadership capability and an ability to manage priorities and work under tight timelines.
- Ability to establish priorities, work independently, and proceed with objectives without supervision.
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 firstname.lastname@example.org