Careers
We offer a competitive benefit package, including medical, dental, vision plan, and 401K.
Please click into any of the open job listings below to review and apply or send your resume and inquiries to noerahr@noerausa.com
Open Positions
Noera’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.Noera 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.
Noera USA, Inc. was established in California in November 2019 and is a wholly owned subsidiary of Hisun Bio Inc. We are dedicated to the global expansion of Hisun Bio Inc. 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 los Angeles, CA Office.
JOB DESCRIPTION
Regulatory Manager (CRM)
Noera USA has an exciting opportunity for an experienced regulatory professional in our Los Angeles, CA office. The position is Regulatory Manager/Senior Manager/Associate Director/Director based on experiences, who will directly report the CEO of Hisun Bio.
Responsibilities:
Act as liaison between Noera USA and Hisun Bio 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.
Noera USA, Inc. was established in California in November 2019 and is a wholly owned subsidiary of Hisun Bio Inc. We are dedicated to the global expansion of Hisun Bio Inc. 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 los Angeles, CA Office.
JOB DESCRIPTION
Regulatory Manager (CRM)
Noera USA has an exciting opportunity for an experienced regulatory professional in our Los Angeles, CA office. The position is Regulatory Manager/Senior Manager/Associate Director/Director based on experiences, who will directly report the CEO of Hisun Bio.
Responsibilities:
Act as liaison between Noera USA and Hisun Bio 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.
REQUIREMENTS
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.
BENEFITS
As a member of the Noera 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.
Noera USA, Inc. was established in New Jersey in November 2019 and is a wholly owned subsidiary of Hisun Bio Inc. We are responsible for all the business development activities for Hisun. Currently we have an opening in our Business Development Department.
The role of the Business Development Manager will be to seek new business opportunities by contacting and developing relationships with potential partners. The goal of this role is to identify and evaluate potential opportunities and contribute to our long-term business growth.
To be successful in this role, you should have previous experience evaluating in/out licensing opportunities. You will use your communication skills to cultivate strong relationships with customers, from first contact until you close the deal. If you are motivated and results-driven, and enjoy working in a team environment, we’d like to meet you.
Business Development Manager
Responsibilities:
-Identify and evaluate potential opportunity targets
-Contact potential partners through cold calls and emails
-Present our company to potential partners
-Build long-term trusting relationships with partners
-Proactively seek new business opportunities in the market
-Set up meetings or calls with (prospective) partners
-Report to the Vice President, Corporate Development on (weekly/monthly/quarterly)
basis
-Stay current with new licensing/partnering opportunities
Qualifications:
The ideal candidate will have:
-BS degree in the life sciences, or relevant field
-Proven work experience and knowledge as a Business Development Representative,
-Familiarity with MS Excel (analyzing/creating spreadsheets and charts)
-Excellent communication and negotiation skills
-Ability to deliver engaging presentations
-Experience with cross-functional/cross-cultural teams in a complex environment is desirable. Travel required.
Languages
English – fluent
Chinese- a plus
Skills
Proficient in Microsoft Office, Excel
BENEFITS
As a member of the Noera 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.
The role of the Business Development Manager will be to seek new business opportunities by contacting and developing relationships with potential partners. The goal of this role is to identify and evaluate potential opportunities and contribute to our long-term business growth.
To be successful in this role, you should have previous experience evaluating in/out licensing opportunities. You will use your communication skills to cultivate strong relationships with customers, from first contact until you close the deal. If you are motivated and results-driven, and enjoy working in a team environment, we’d like to meet you.
Business Development Manager
Responsibilities:
-Identify and evaluate potential opportunity targets
-Contact potential partners through cold calls and emails
-Present our company to potential partners
-Build long-term trusting relationships with partners
-Proactively seek new business opportunities in the market
-Set up meetings or calls with (prospective) partners
-Report to the Vice President, Corporate Development on (weekly/monthly/quarterly)
basis
-Stay current with new licensing/partnering opportunities
Qualifications:
The ideal candidate will have:
-BS degree in the life sciences, or relevant field
-Proven work experience and knowledge as a Business Development Representative,
-Familiarity with MS Excel (analyzing/creating spreadsheets and charts)
-Excellent communication and negotiation skills
-Ability to deliver engaging presentations
-Experience with cross-functional/cross-cultural teams in a complex environment is desirable. Travel required.
Languages
English – fluent
Chinese- a plus
Skills
Proficient in Microsoft Office, Excel
BENEFITS
As a member of the Noera 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.