Job-ID31623667Reference25-04672 Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines. Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale-up, validation, and post-approval changes. Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives. Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes. Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives. Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed. Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders. Requirements: Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline. 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry. Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA). Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex). Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders. Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment. Detail-oriented mindset with a focus on quality, accuracy, and compliance. Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred. Regulatory Affairs Certification (RAC) is a plus.
...world-class investors. Ambition is sacred to us, and weve built a product that takes that seriously.Were seeking an experienced life coach to work with clients looking to grow personally and live with more intention. This role includes guidance on goal setting, self-...
Class B CDL Shuttle Bus Driver JobJob DescriptionCity Center Parking is currently looking for part-time or full-time CDL Shuttle Bus Drivers to work at our Portland locations.Key Responsibilities:Drive shuttle bus route for Central Eastside Industrial District...
...This positions role is to maintain the daily operations of the elevator s physical plant.The Elevator Operator reports to the Elevator Foreman and will provide lead supervisor guidance in the absence of the Elevator Foreman.This position is 90 to 95% physical labor...
...respect Position Purpose: Food and food service delivery Drivers fulfill a critical role in the countrys food supply chain. Our... ...company building lasting relationships with our customers! As a Shuttle Driver, you will play a vital role in the operation of our...
...Job Description Job Description A manufacturing company is seeking a CNC Machinist who can also program Grinding and Milling Machines. Client has some flexibility, so you can work either 5-8 hour days or 4-10 hour days. Responsibilities: Run CNC Surface Grinders...