Job Description

Overview

Job Description

The Associate Director, CMC Regulatory Affairs, Biologics executes multi-product global regulatory CMC strategies for investigational and marketed products, with a focus on biologics. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise or mentor other regulatory staff.

Key Duties and Responsibilities

• Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Develops global CMC regulatory strategies for one or more investigational and/or marketed products, including lifecycle management for combination biologic drug products
• Leads regulatory colleagues in development of global CMC regulatory strategies and submissions
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
• Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Knowledge and Skills

• Excellent interpersonal skills to communicate difficult concepts and persuade others
• Strategic thinking and strong problem solving skills
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
• Strong knowledge and experience in biologics, including BLA and lifecycle management experience

Education and Experience

• Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
• Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience

#LI-EE1 #LI-Hybrid

Pay Range

$161,400 - $242,100

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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