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.
...Security Guard Wage: $18.00/ hour Driver Certification We help make your world a safer place. Are you interested in being... ...culture, help define who we are and guide our actions. No experience necessary! If you have retail, food service or hospitality...
...Fabricator Artex Manufacturing - Redwood Falls, MN Farmers Union Industries, LLC, also known as FUI, is a leading agricultural-based manufacturing company headquartered in Redwood Falls, MN. Our current operations include Central Bi-Products, Northland Choice, Midwest...
...Inyo County Sheriff Office Correctional Officer PositionsThis is a continuous recruitment for the Inyo County Sheriff Office Correctional Officer positions. Applications will be accepted on an ongoing basis and qualified applicants will be placed into an eligibility pool...
...wants to make getting the job you need as easy as possible. Job Description Randstad Williamson County is looking for an Accounts Receivable Specialist to work for a fast growing company in the area. In this position, the candidate will be responsible for: -...
...The Billing Specialist is responsible for managing day-to-day invoicing and accounts receivable activities while working closely with the Accounting Manager. This role is ideal for a detail-oriented professional who is comfortable with construction and project-based...