regulatory associate i/ii

1 week ago

Redwood City, California, United States Adicet Bio, Inc Full time
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.

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