US Regulatory Project Manager – Associate Director/Director (Remote)
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.
The position will be responsible for project management of US and global regulatory submissions and activities in support of biologic investigational drugs being developed for the treatment of cancer. The ideal candidate must possess knowledge and experience in regulatory affairs and drug development. This candidate must have strong communication skills, be able to work in a matrixed and fast paced environment, possess strong problem-solving abilities, and show a deep commitment to excellence.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Provide oversight of US and global regulatory submissions, working with internal cross-functional teams and external CROs.
- Lead cross-functional activities, such as conducting kickoff meetings for regulatory submissions (IND filing, annual reports, briefing documents for FDA meetings).
- Responsible for coordinating and facilitating cross functional regulatory strategy meetings.
- Develop and maintain project plans; track and manage timelines for regulatory dossier preparation, review, and submissions.
- Identify and drive regulatory system improvement activities.
- Other projects or responsibilities as may be required.
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:
· Bachelor’s degree in a science related field.
· A minimum of 5 years in biopharmaceutical industry with previous experience in regulatory affairs project management.
· Requires solid understanding of applicable regulatory regulations, guidelines (e.g. FDA, EMA, ICH) and eCTD knowledge.
· Project management skills
· 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.