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Description:
JOIN US!
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
REGULATORY ASSOCIATE I/II
Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as a REGULATORY ASSOCIATEI/II. This position will be responsible for supporting the Sr. manager of regulatory affairs and assisting in developing and executing regulatory activities in support of the CMC, nonclinical, and clinical development for our early development pipeline products within the Regulatory Affairs department. The role would require a scientific and/or pharmacological background with an understanding in relevant regulatory guidelines to support the Manager and contribute to all regulatory support activities. The ideal candidate would be agile and curious to expand their regulatory knowledge and skills.
QUALIFICATIONS:
- Bachelor’s degree in life sciences or a relevant field in an advanced degree preferred.
- 2-5 years working within the biotech/pharmaceutical industry. 1+ years of experience in regulatory affairs preferred.
- Prior experience with cell or gene therapies is highly preferred.
- Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines.
- Ability to prioritize projects based on input from Manager
- Ability to work independently on projects once provided with sufficient guidance
- Strong verbal and written communication skills and interpersonal skills.
- Proficiency in Microsoft Word and Excel.
- Experience with Microsoft Power Point, MS Project and Smartsheet preferred.
- Responsible for development and acquisition of required regulatory skills and knowledge with mentoring by manager and other subject matter experts.
How To Apply:
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Responsibilities:
- Support, prepare and/or coordinate routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines.
- Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met.
- Interface with functional areas (CMC, Nonclinical, Clinical) to obtain information required for regulatory submissions.
- Assist the team in executing regulatory strategy options and providing relevant regulatory support.
- Monitor regulatory environment for changes to requirements.
- Maintain current knowledge and expertise of FDA/EMA regulations and ICH guidelines.
- Collaborate with other functional areas in preparing and maintaining SOPs and appropriate regulatory operating guidelines.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
- Serve as Regulatory support team member assisting cross-functional project teams to achieve project milestones/goals.
