Regulatory Affairs Specialist

Pe Global

Tipperary

PE Global are currently recruiting for a Safety Specialist for a client site in Tipperary. Provide Regulatory support for the manufacture of Clinical and Commercial pharmaceutical products on site. ( 12 month contract. Regulatory activities include: Regulatory “Point of Contact” between site and corporate Regulatory personnel, for clinical and commercial small molecules and helping to execute site Regulatory strategy for DS / DP manufactured. Support Corporate Regulatory personnel with the preparation of new filings and maintenance of dossiers in the post approval world for global registrations for small molecules. Provide regulatory direction to the site for products of responsibility. Support the plan and execution of regulatory strategies and priorities through effective partnerships with the site and global CMC product responsible scientists. Manage the site submission activities and timelines to support global filings for products of responsibility. Correspondence and interaction with Global CMC affiliates and other scientists to support either new or in line product filings worldwide. Maintain working knowledge of current and emerging government and worldwide requirements for initial registration, re-registrations and post approval changes. and evaluate impact to the site. Assure that filed information on current approved dossiers is kept updated. Provide input to project schedules, in terms of Regulatory activities (i.e. what reports are required to be support Regulatory filings, and timelines for when these reports should be available to support Regulatory filings – link in to IND / IMPD/ NDA/ MAA timelines for filings – to ensure the site has an integrated schedule/ plan for product tech transfers. Provide Regulatory support, guidance and advice, in terms of supportive data for filings (i.e. reports and design of technical reports, to support global applications i.e. IND/ IMPD, NDA, MAA etc. Review site technical reports when complete from Regulatory perspective – (for reports that could be used to support global Regulatory filings. Provide training to the site personnel regarding product registration requirements and applicable regulations and guidelines. Provide Regulatory support as required during HA inspections. Leverage off the global networkin terms of Regulatory guidance and support for small molecules when required. Provide guidance and support to the site in terms of Regulatory business processes and systems. Review site change control to provide pre-read on impact to Clinical / commercial licences for proposed changes. Co-ordination of Health registration requests. Qualifications Degree in Chemistry, Chemical engineering, Pharmacy, Biological Sciences or related discipline. Advanced degree preferred. Experience Min 5 Years’ experience I the pharmaceutical industry -- Regulatory experience in Research ,Development and / or manufacturing. 3 years regulatory / QA experience required in the Pharmaceutical industry. Direct experience with regulatory submissions desirable. Proven ability to effectively influence site and global personnel. Strong knowledge of regulatory and compliance guidelines within the pharmaceutical manufacturing. Interested Candidates should send their CV to audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2391 days ago