Senior Manager, Regulatory Affairs (Beijing)
Location: Beijing, China
The selected candidate will contribute to the development and implementation of regulatory strategy for assigned projects, serve on project teams and sub teams, and communicate with relevant regulatory agencies, as requested.
Key Responsibilities include:
- Provide the registration scenarios, risk factors and timelines for the responsible development projects under the guidance of line manager
- Plan and leading the execution of CTA document (including variation) preparation and related regulatory filings for assigned projects consistent with applicable regulations, guidelines, and standards
- Create timelines for regulatory filings, coordinate with team members and managers responsible for drafting and reviewing various components, and work with the project team to execute the filing on time
- Ensure that team members use the correct document templates, review documents for consistency, accuracy, and compliance with regulatory requirements, and coordinate the document review process with other reviewers and authors to facilitate completion of high-quality documents
- Compile all documents necessary for regulatory filings in China.
- Serve as a local representative to coordinate the regulatory activities in project related global regulatory team.
- Serve as a local representative to liaise with Global regulatory managers on the related regulatory issues on the responsible projects with the guidance of line manager.
- Support line manager on the communication with HAs in China to properly address the concerns on projects; and coordination on related HA meetings.
- Monitor and review regulatory agency communications such as changes to regulations and guidelines, and summarize these for team members, as appropriate
Preferred Qualifications include:
- Bachelor’s degree or above in Pharmacy, Medical, Biology or related field.
- >10 years of experience in Pharmaceutical or CRO company, at least 6 years in Regulatory of MNC
- Good track record
- Works independently
- Strong team player, experience in working with global cross-functional team is a plus
- Experience in regulatory strategy discussion, submission/approval in MRCT is a plus
- Experience in drug development is a plus
- Experience in working with other Asian Pacific regions is a plus
- Excellent professional and interpersonal skills
- Excellent oral and written communication skills
- Proficient in oral and written English
- Ability to work efficiently and cooperatively in a virtual company environment
- Goal oriented and ability to deliver on timelines and commitments
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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