Senior Manager or Associate Director, CMC Regulatory Affairs

Location
Philadelphia, PA, United States
Posted
Jun 02, 2022
Ref
3099830517
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

The Senior Manager / Associate Director, CMC Regulatory Affairs will be an integral member of the Century Regulatory Affairs (RA) team providing regulatory input related to Chemistry, Manufacturing and Control (CMC) development of Century's pipeline developmental product candidates. The role will partner with key cross-functional stakeholders to define and implement global regulatory strategies in alignment with the company's overall business priorities, to expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to contribute toward growing and shaping the CMC RA function of a biotech start-up.

Responsibilities:
  • Participate in product development team(s) and provide regulatory CMC input on the definition and execution of cross- functional product development strategies.
  • Proactively communicate CMC regulatory risks and issues throughout product lifecycle in a timely manner to product development teams and relevant technical stakeholders. Participate in technical risk assessment exercises as needed.
  • Partner with Head of CMCRA and Regulatory Program Lead to develop and execute global health authority interaction and submission plans that comply with local regulatory requirements and commitments.
  • Partner with CMC and/or cross-functional stakeholders to develop and deliver regulatory dossiers (e.g. IND / IMPD / Master File submissions, amendments, annual reports) and health authority interaction briefing documents, manage the update of regulatory dossiers as required throughout product development lifecycle. Completion of post-interaction activities and the planning / implementation of follow-up actions as appropriate.
  • Define, manage and coordinate submission workflows with internal and/or external regulatory operations and/or publishing vendors. Complete review and finalization of submission documents to ensure compliance with internal submission quality standards and regulatory guidance requirements.
  • Provide regulatory assessment on manufacturing changes and quality compliance topics to cross-functional technical stakeholders and/or following the prevailing quality management procedures.
  • Partner with Regulatory Operations to support the development and maintenance of regulatory templates, files and regulatory correspondence archives.


Qualifications:
  • Bachelor (BS or BA) in a biological science, engineering, or a related discipline such as biology, microbiology, virology, molecular biology, biomedical / biochemical / chemical engineering, or biochemistry. Advanced degree (M.S., Ph.D., PharmD) is preferred.
  • 5 to 10 years relevant experience in the biopharmaceutical or biotech industry experience, with focus on CMC cell & gene therapy or biologics development.
  • Regulatory CMC strategy development on cell / gene therapy product(s) is highly desirable.


Requirements:
  • Demonstrate clear understanding of CMC regulatory affairs roles and responsibilities, and regulatory submission requirements in the development of complex gene-modified cell-based therapy products
  • Prior knowledge or working experience on combination product and medical device regulatory risk assessment and strategy development is highly preferable.
  • Knowledge of and ability to interpret up-to-date cell and gene therapy health authority regulatory requirements or guidelines in major markets such as US & EU. Prior exposure on global CMC regulatory interactions for cell / gene therapy product candidates and/or CMC regulatory intelligence is preferred
  • Working knowledge of biopharmaceutical drug development processes and concepts, including but not limited to, biologics and/or cell therapy drug substance / drug product process development, analytical method development, raw material sourcing and control, analytical comparability approaches, GxP/ICH guidelines, manufacturing and quality control.
  • Ability to develop/maintain strong collaborative relationships with CMC technical development and cross functional teams, handle and prioritize multiple projects and work independently.
  • Excellent communication, verbal and written skills with attention to detail. Possesses strong critical and analytical thinking.
  • Strong computer software or systems software skills such as MS Word, MS Excel. MS PowerPoint, PDF publishing and editing, flow diagrams editing e.g. MS Visio, literature reference, documentation review and/or management tools and platforms. Prior experience in use of PleaseReview and Master Control Regulatory Module is a plus.
  • Flexible and adaptability in order to take on new, unexpected or urgent activities
  • High level of interest in continued learning in order to develop knowledge and new professional skills
  • Minimal (≤10%) travel may be required


Century Therapeutics, Inc. is an Equal Employment Opportunity/Affirmative Action Employer - Minority/Female/Disability/Veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.

Featured benefits

Employer-provided

Medical insurance, dental insurance, vision insurance, 401(k), pension plan, paid maternity leave, paid paternity leave, commuter benefits, and disability insurance