Senior Manager, Regulatory Affairs CMC
Location: South San Francisco, California, United States
The selected candidate for Sr. Manager, Regulatory Affairs CMC will play a key role in the CMC regulatory strategy for the Virology small molecule products. They will have an opportunity to work on a variety of projects from preclinical through commercial launch.
Key responsibilities include:
- Play a key role in the development of the CMC regulatory strategy for Virology/HBV (small molecule) products
- Work closely with CMC team to provide phase appropriate regulatory requirements for API and drug product manufacture, analytical development, and specifications
- Guide the CMC subteam in developing the overall content and timing of CMC regulatory filings consistent with regulations and guidelines in relevant countries
- Preparation of IND/CTA CMC and Quality sections including authoring and/or reviewing sections drafted by other team members to ensure compliance ICH requirements, regional requirements and scientific and company policies and procedures
- Liaise with Assembly’s Quality Assurance (QA) group to facilitate coordination of regulatory CMC and QA activities such as change controls and deviations.
- Collaborate with global regulatory leads to deliver CMC submission content ensuring filings are performed on time
- Manage external parties such as qualified persons (QPs) and regulatory/QA personnel at contract manufacturers to facilitate successful release, import or export of drug needed for clinical trials
- Identify and assess regulatory risks and risks to timelines for Virology/HBV programs
- Monitor and review regulatory agency communications related to CMC/Quality such as changes to regulations and guidelines, and summarize these for team members, as appropriate
Preferred Qualifications include:
- Bachelor’s degree in a scientific discipline with 10+ years of industry experience. Candidates with a Master’s or PhD will be considered in lieu of years of experience. Preference given to candidates with small molecule experience
- Current knowledge of international guidelines and regulations pertaining to chemistry, manufacturing and controls, Quality, and good manufacturing practice and their appropriate application for clinical trial material manufacturing and preparation of marketing applications
- Knowledge of and experience with eCTD structure and electronic filing procedures
- Experience with developing control strategies for marketing applications
- Experience with submissions globally including in US, Canada, EU, China, and other APAC regions
- Excellent interpersonal skills along with verbal and written communication skills
- Ability to work efficiently and cooperatively cross functionally
- Detail oriented and ability to deliver on timelines and commitments
- Proficiency in Microsoft Word
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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