Device Regulatory CMC - Manager (Contract) 323232 at Vertex Pharmaceuticals | Torre
Device Regulatory CMC - Manager (Contract) 323232
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Vertex Pharmaceuticals

Device Regulatory CMC - Manager (Contract) 323232

Vertex Pharmaceuticals
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Freelance
Recurrent
Compensation
USD75 - 80/hour
location_on
Remote (for United States residents)
Shared by
Julien PETIT
 24 days ago

Responsibilities

The Chemistry Manufacturing Controls Manager – Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.Key Duties and ResponsibilitiesReviews CMC sections of regulatory submissions in support of development and commercial device programsContributes to the development of global regulatory CMC strategies for commercial drug-device combination productsParticipates effectively on cross-functional teams (including device product development, quality, clinical development, human factors, analytical development, marketing) and may serve as the primary regulatory CMC contact for assigned products and projectsReviews device development documentation as needed to support design controls of drug-device combination productsSupports regulatory assessment and guidance on product compliance topics including change controls and process improvementRequired Education Level & ExperienceBachelor's degree, with a preference hanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science fieldTypically requires 4 years of experience rmaceutical industry or related field, or the equivalent combination of education and experienceExperience supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringesExperience supporting Human Factors studies for devices and combination productsPreferred experience with infusion systems/devices for drugs/cell therapiesRequired Knowledge/SkillsStrong interpersonal skills to exchange complex information with others and to guide othersKnowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)Proficiency in regulatory (FDA, Notified Body, MDCG, EMA, ISO, etc.) guidelinesStrong problem-solving skillsAbility to collaborate and communicate ar, complete, timely and consistent mannerStrong sense of planning and prioritization, and the ability to work with all levels of managementSound knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.)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.
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