Regulatory Affairs Chemistry Manufacturing Controls Manager
Regulatory Affairs Chemistry Manufacturing Controls Manager
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$ 122600 - 183900
1 Vacancy
Job Description
Job Description
General Summary:
The Regulatory Affairs Chemistry Manufacturing Controls (CMC) Manager will influence the execution of multiproduct global regulatory CMC strategies for investigational and marketed products. The scope of this role includes leading and managing a specific products life cycle including post approval variations and line extensions within approved markets and global expansion in new markets. This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various crossfunctional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated intothe life cycle of investigational and commercial programs.
Key Duties and Responsibilities:
- Lead team to author review and approve 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 investigational and/or commercial products
- Provides regulatory CMC guidance to crossfunctional teams and key stakeholders
- Influences regulatory assessment and guidance on product compliance topics including change controls deviations and GMP investigations
- Participates effectively on crossfunctional teams and serve as the global regulatory CMC lead for assigned products and projects
Knowledge and Skills:
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in global regulatory guidelines (FDA EMA Health Canada and ICH)
- Experience in the preparation including writing of CMC submissions
- Strategic thinking and strong problem solving skills
- Ability to collaborate and communicate 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
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
- Sound knowledge of cGMP FDA EMA ICH
- Experience using the Veeva Vault Regulatory Information Management System (RIM)
Education and Experience:
- Bachelors degree in Biology Chemistry Pharmacy Regulatory Affairs for Drugs Biologics or Medical Devices or another related lifescience field
- Typically requires 4 years of experience in the pharmaceutical industry or related field or the equivalent combination of education and experience
Pay Range:
$122600 $183900Disclosure 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 jobrelated factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive marketleading 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 weeklong 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:
HybridEligible Or OnSite EligibleFlex Eligibility Status:
In this HybridEligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. OnSite: work five days per week onsite with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify 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
Required Experience:
Manager
Employment Type
Full-Time
