Skip to main content

This job has expired

You will need to login before you can apply for a job.

REGULATORY ASSOCIATE I/II

Employer
Adicet Bio, Inc.
Location
Redwood City, CA
Start date
Mar 31, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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 associate I/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.

Key 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.

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.

 

Benefits

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

 To ensure the wellness and protection of you and your loved ones, we offer:

Comprehensive health plans (medical, dental, vision, etc.); Flexible Health and Commuter Spending Accounts (FSA) and company matched Health Savings Account (HSA). We also offer a life, AD&D, short- and long-term disability insurance and legal, pet and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer: generous paid time-off including 17 company holidays with end-of-year shutdown, vacation, sick time; and paid parental leave.

With “Develop” as one of our Values, we also offer an Educational Reimbursement program which is a benefit that allows employees to develop new skills or enrich the ones they currently possess. Employees can receive reimbursement on a pre-tax basis up to $4k per calendar year. This is in addition to an expertly curated curriculum we offer through LinkedIn Learning.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with: a free onsite gym and various other fitness options; abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain); lunches (delivered onsite) and fully stocked breakrooms. insurance, legal, pet, and various other voluntary insurance programs.

 

Pay Range$105,000—$146,000 USD

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Company

Adicet Bio, Inc. is a privately held, pre-clinical stage biotechnology company developing novel universal immune cell therapies based on gamma delta T cells engineered with Chimeric Antigen Receptors.  Adicet is also focused on identifying and validating cancer specific targets directed to the intracellular proteome and then generating T Cell Receptor-like monoclonal antibodies (TCRLs) directed to these cancer-specific peptide targets presented by MHC Class I complexes. These TCRLs are being used to arm T cells or as T cell engagers in solid tumors. In August 2016, Adicet entered into a strategic collaboration with Regeneron Pharmaceuticals, Inc. to develop next-generation engineered immune-cell therapeutics using Adicet's gamma delta T cell allogeneic platform technology.
 
For more information, please visit our website at http://www.adicetbio.com.

Company info
Website
Location
1000 Bridge Parkway
Redwood City
California
94065
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert