Contract Manager / Senior Manager, Regulatory Affairs CMC
Location: South San Francisco, California, United States
The contract Manager / Senior Manager, Regulatory Affairs CMC will play a key role in the CMC regulatory strategy for Virology small molecule products, working on a variety of projects from preclinical through commercial launch. This is a six month contract assignment covering a leave of absence. There is a possible opportunity for full-time employment in 2022, or earlier if business needs require it. Independent contractors will be paid through our partner Eastridge Workforce Solutions. Remote contractors will be considered.
The scope of work includes:
- 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
Qualified Contractors should have experience that includes:
- Typically a Bachelor’s degree in a scientific discipline with sufficient years of industry experience to successfully deliver on the general scope of work as outline above. Contractors with Regulatory CMC small molecule experience will be considered uniquely qualified for this role.
- 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 an ambitious clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world. We are currently focused on 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.
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 set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.
As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. 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.
Information for Recruitment Agencies
Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
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