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Regulatory CMC Manager - Cell & Gene Therapy (Contract)

Vertex Pharmaceuticals -
Remote

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Job Details

Full-time
$70 - $80 an hour

Qualifications

FDA submissions
Drug regulation
Bachelor's degree
Compliance documentation
Chemistry, manufacturing & controls
Regulatory submission editing and review
Biomedical regulatory compliance
Cross-functional collaboration
Cross-functional communication
Documentation reviews

Full Job Description

Job Description:

The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable international regulatory requirements are considered and appropriately incorporated into the lifecycle of cell and gene therapy programs.

Key Duties & Responsibilities

Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Contributes to the development of global regulatory CMC strategies for commercial products
Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
Provides regulatory CMC guidance to cross-functional teams and key stakeholders
Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Education Level & Experience

Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in FDA, EMA and international regulatory guidelines
Experience in the preparation, reviews and submissions of CMC post approval variations
Strong sense of planning, strategic thinking and problem-solving skills
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Capable of strategic thinking with ability to resolve complex and ambiguous situations
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
5 years of Regulatory CMC experience, including Cell & Gene Therapy Regulatory CMC experience.

Contract length: 12 months with the chance to extend.

Pay Range:

$70/hr. - $80/hr.

Shift/Hours:

Monday–Friday; Remote: EST hours

Requisition Disclaimer:

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at [email protected].

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at [email protected]. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors

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