Contract Manager / Senior Manager, Regulatory Affairs CMC

Department: Regulatory Affairs

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.


Apply for this Job

* - required fields





Attach File or Paste

Attach File or Paste







U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at this company are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.



If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.



BACK | NEXT