Lead CMC Regulatory Affairs -Assoc. Dir. / Director (Remote)

Location
San Diego, CA
Posted
Jul 17, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

About the Company

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

Job Summary

This position will lead the Global CMC Regulatory Affairs and is responsible for CMC regulatory strategy and operational oversight of CMC regulatory submissions and activities in support of biologic investigational drugs being developed for the treatment of cancer. The ideal candidate must possess in-depth experience in biologics CMC and regulatory affairs in drug development. This candidate must have strong communication skills, ability to work in a matrixed and fast paced environment, possess strong problem-solving abilities, and show a deep commitment to excellence.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Devise CMC regulatory strategic plans together with project teams to support drug development. Key focuses include: understanding regulatory guidance and process, proactively planning and negotiating with regulators to achieve business objectives.
  • Execute regulatory strategies for CMC process development, validation, and implementation of changes to ensure Regulatory Agency approvals within specified timelines and supply chain for clinical studies.
  • Act as a CMC regulatory expert, ensure compliance with regulatory procedures, lead the planning and preparation of regulatory CMC documents, lead internal review /approval process for CMC related submissions and regulatory questions, and provide guidance for internal and external collaborators.
  • Provide leadership and support for all CMC focused regulatory agency interactions and meetings.
  • Proactively identify program CMC issues with CMC team and implement appropriate regulatory strategies to mitigate risks.
    • Other projects or responsibilities as may be required.

    Qualifications:

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job.

    Minimum Qualifications – Education and Experience

    ·       A minimum of 5 years in biopharmaceutical industry with previous experience in regulatory affairs CMC for biologics.

     

    Preferred Qualifications – Education and Experience

    ·       Advanced degree in a science related field. Cell and biological education preferred.

     

    ·       Previous research, process development or manufacturing experience with biotechnology products is strongly preferred.

     

    Core Competencies

    ·       A strong collaborator who works effectively on a cross-functional team

    ·       An outstanding communicator who has the ability to influence others based on scientific rationale and data, while being       open to listening and learning from others

    ·       A creative problem solver with analytical and critical thinking skills.

    ·       Strong organizational and time-management skills and the ability to manage several projects simultaneously.

    ·       A self-motivated learner with the mindset to continue growing professionally in a fast-paced working environment.

    Equal Opportunity Employer

    Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant.

    Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation.

    Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.

    Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

    Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.