Associate Director CMC Regulatory

Are you a Senior Manager or Associate Director with expertise in CMC Regulatory seeking a long-term career home? *APPLY BELOW*Join a global leader in the pharmaceutical industry known for its people-first culture, dedication to volunteerism, and commitment to philanthropy! This role offers a unique blend of a supportive, close-knit environment within the larger radiopharmaceuticals team"”providing you with high visibility and long-term stability within an established corporate structure. Be part of a team that values innovation, collaboration, and meaningful contributions to advancing healthcare.Ideal candidate background: Radiopharmaceuticals or small molecule expertiseSchedule: Fully remote andor 1 day a week in Philly depending on the candidate's location+++What you will accomplish: Develop and implement tailored CMC regulatory strategies for specific countries.Lead CMC regulatory submissions, overseeing the entire submission process, including project management, cross-functional coordination, timelines, drafting, reviewing, formatting, and publishing.Respond to regulatory agency inquiries, leading and contributing to responses as needed.Create and maintain tools to update cross-functional teams and leadership on the progress of CMC regulatory projects.Assess global change controls for their impact on country-specific CMC regulatory requirements.Stay updated on regulatory requirements relevant to CMC in applicable regions.Support ongoing CMC development projects, offering guidance from a regulatory perspective.Gain working knowledge of the company's radiopharmaceutical manufacturing and analytical procedures.Review technical documents, such as testing protocols and technical reports, from a regulatory standpoint.What you must have:Bachelor's or Master's degree in Chemistry, Pharmacy, or a related fieldAt least 5 years of experience in pharmaceutical development, manufacturing, or CMC regulatory affairsBackground in CMC technical writing is beneficialWhat we hope to find:Strong technical writing skillsBackground in chemistryProven ability to work independently and collaboratively within a teamStrong organizational skills with attention to detailProficiency in Microsoft OfficeWillingness to travel up to 10% within the U.S. and internationallyWhat you have to look forward to:401k at a 6% match with immediate vestingPension - 5-year vesting period2 companywide paid shutdown weeks. Summer shutdown, the week of the 4th of July & Winter shutdown, the week following ChristmasOther generous time off options include personal business time, floating holidays, caregiver time, and unlimited sick timeIf you're looking for a career with growth potential"”not just a temporary role"”this could be the perfect opportunity for you! We want to hear from you if you have the skills and experience listed above. And if you're unsure if this role is the exact fit but have CMC Regulatory experience in small molecules, go ahead and apply! Let's have a conversation to explore what really matters to you and how we can support your career goals.

Created: 2024-11-06