Job description
Job Description
The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.
This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.
Key Duties and Responsibilities
Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions.
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
Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Knowledge/Skills
Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
Strong problem-solving skills and the ability to present the overall assessment for management alignment
Ability to collaborate and communicate in an open, clear, complete and timely manner
Strong sense of planning and prioritization, with demonstrated results
Required Education Level & Experience
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
Typically requires 5 years of experience in the pharmaceutical industry or related field
Experience supporting Small Molecule programs required
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
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No C2C or Third-Party Vendors
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.