• Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
• Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers
• At least a Bachelor Degree required. Master’s Degree or PhD preferred
candidate who has strong experience in In-vitro Diagnostic (IVD) domain.
Candidate should have min of 6-8 yrs of experience and at least 5 yrs of experience in IVD domain
Should be knowledgeable on new EU regulations for IVDR
March 2, 2018 – Regulatory Manager Specialist – p b Job Description: /b /p ul li Responsible for writing drug regulatory submissions/licenses including New Drug Application (NDA), ANDA’s,
The detail-oriented Submission Specialist is responsible for all paper and electronic publishing activities for regulatory submissions to global health authorities following FDA and ICH guidance
Participate in draft and final document reviews with a focus on managing quality control of document preparation of Word and PDF documents to health authorities
Proofread, review and edit Word documents for grammar, accuracy, and consistency
Prepare submission ready documents that includes bookmarking and hyperlinking
Overall operational planning, coordination and support of compliant submission dossier publishing activities with the ability to manage publishing timelines for the compilation of submission and maintenance of regulatory filings
Coordinate document deliverables and submission timelines with publishing vendor
Plan, prepare and publish submission documents (IND’s, CTAs, Amendments, DSURs, IMPDs, SUSARS, etc.) for both electronic and pap
Individual will work in the Packaging Development Group. The group is responsible for all packaging development related issues. Change control management, plant support as well as support of corporate initiatives are its primary function.
The individual is responsible for issues associated with the packaging of solid, liquid, cream and ointment OTC and nutritional products manufactured at the Myerstown, PA location.
Responsibilities include, but are not limited to, package development, design and testing; identifying meaningful component specifications; qualifying components and packaging operations; troubleshooting commercial packaging operations; and implementation of quality and cost improvement programs.
Also, work within established guidelines to implement new packaging projects that have been initiated by the Marketing/I&D/Product Supply Departments in Morristown.
Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance.
Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Submit notification to the Notified Body about significant changes to CE marked products in a timely manner.
Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
January 27, 2018 – Regulatory Affairs Specialist, AdPromo – ul li US Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for actively contributing to the implementation of regulatory