Manager Regulatory Submissions (eCTD)

Assume a key role responsible for preparing regulatory submissions, including INDs, ANDAs, and NDAs, and also provide counsel on submission strategies for a broad base of pharmaceutical products.  Our client is a dynamic and growing pharmaceutical company developing a broad base of pharmaceutical products. You will be responsible for regulatory submissions, submission strategies, acting as the companies’ primary liaison with the FDA for regulatory submissions, and developing / maintaining a training program on electronic regulatory submissions. In addition, you will select and work with vendors to support eCTD readiness, and will provide guidance to CROs on eCTD and other submission related issues.Utilize your experience with electronic submissions (in eCTD format), a strong working knowledge of FDA /  ICH / EU guidelines, and also bring an in-depth understanding of software systems for electronic submissions (such as CoreDossier, Insight, eCTDXpress, or equivalent) to a key strategic position.An exciting opportunity to work with an experienced team, in a collaborative work environment, and leading the company to fully electronic submissions. A key leadership role with excellent career growth prospects within the company.CONTRIBUTIONS:·  Prepares regulatory submissions in eCTD format.·  Assist in the development of regulatory strategies and compliance.·  Provide regulatory counsel for drug development programs internally and externally.·  Maintain liaison with external clients, internal personnel and external consultants.·  Manage activities and budgets to achieve program objectives.·  Responsible person for continuing to lead the company toward fully electronic submissions.·  Be the primary liaison with Informatics for identifying and procuring appropriate hardware and software to keep the company updated with eCTD requirements. ·  Responsible person to maintain/update a training curriculum on eCTD submissions.·  Select vendor(s) to support eCTD readiness, implementation activities, and training process. ·  Interact with counterparts in CROs or development partners on the eCTD or any submission issue. ·  Liaison with the FDA to receive expert advice on the electronic submissions. ·  Oversee the Regulatory Submissions Group and ensure timely coordination and publishing of various regulatory submission documents. CAPABILITIES:·  Bachelors degree in a science / health related field (Pharmacy, Chemistry, Microbiology, or Biology).·  Minimum 3 years of experience in regulatory submissions.·  Minimum 2 years experience in the area of electronic submissions in the pharmaceutical industry or equivalent.·  In depth understanding of CoreDossier, Insight, eCTDExpress (eCTDXPress), or comparable software system. Knowledge and experience with CoreDossier would be a best fit. ·  Expert knowledge of the ICH and FDA eCTD specifications; Working knowledge of EU eCTD specifications a plus.·  At least one year of experience in leading a successful electronic submission of IND, or marketing application.·  Superb experience with the preparation of INDs, NDAs.·  Thorough understanding of new drug regulations.·  Effective facilitator and negotiator. Excellent written and oral communication skills.·  Computer literate. Excellent organizational skills, strong project management skills. MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Job location not provided JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee COMPANY: MRINetwork CONTACT NAME: Fred Gordon EMAIL: Apply by Email