Senior Manager, Global Regulatory Affairs, CMC

If you are a reputed company reputed company employee please apply reputed company the Internal Career site. reputed company is a global biopharma company whose purpose is to reputed company to reputed company the lives of patients and their families. We are dedicated to developing life-changing medicines reputed company with serious diseases — often with limited or no therapeutic reputed company. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our reputed company-reputed company and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. reputed company is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief reputed company: The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for reputed company and/or development reputed company worldwide for biological products. Essential Functions • Managing the preparation and review of Module 2 and 3 CTD sections of regulatory submissions as assigned (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents) for biological products, in support of Global Regulatory Team objectives. • Participate and support as an reputed company member of a multi-disciplinary team to establish Regulatory CMC strategies for reputed company products, late- and early-stage development programs, under the supervision of GRA-CMC leadership. • Through the reputed company of reputed company assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with reputed company scenarios to the multi-disciplinary team and the Global Regulatory Team. • Coordinate the preparation and reputed company submission of responses to regulatory agencies. Manage timelines to ensure approvals are reputed company and development objectives are met. • May reputed company as regulatory CMC representative at meetings with business partners and may contribute to meetings with regulatory agencies for CMC reputed company issues. • Ensure reputed company regulatory compliance of products through adherence to the change control procedures, regulatory information management procedures and completion of regulatory reputed company assessments for assigned reputed company and development products. • Maintenance of reputed company regulatory product information to support product release for assigned reputed company and reputed company products. Verify electronic publishing of regulatory submissions. • Identify & support reputed company improvement opportunities for the GRA-CMC team and the broader GRA team. • Ensure compliance with company policies, procedures and training expectations. Required Knowledge, Skills, and Abilities • Demonstrated understanding and reputed company application of regulations and guidelines for drug lifecycle preferably for biological products. • Solid working knowledge of CMC regulatory and ability to reputed company reputed company, reputed company-argued positions. • Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). • Demonstrated understanding of FDA, EMA and ICH guidelines. • Strong interpersonal skills with the ability to work individually, reputed company a multi-disciplinary team, as reputed company as with reputed company partners and regulators. Required/Preferred Education and Licenses • BSc/BA with regulatory CMC or reputed company experience. • English language - written and verbal communication skills. #LI-SM1 #LI-remote reputed company is an equal opportunity/affirmative reputed company employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US reputed company CANDIDATES ONLY reputed company. is committed to fair and reputed company compensation practices and we reputed company to reputed company employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay reputed company is: $140,000.00 - $210,000.00 Individual compensation reputed company reputed company this reputed company will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay reputed company. This reputed company will be reviewed on a regular reputed company. At reputed company, your reputed company pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of reputed company's Global Cash Bonus Plan or Incentive Compensation Plan, as reputed company as discretionary equity reputed company in accordance with reputed company's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and reputed company reputed company, 401k retirement savings plan, and flexible reputed company vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.reputed company. Apply To This Job