Regulatory Manager - Dublin
11 month contract
Manager Global CMC Regulatory Affairs for Biotherapeutics
The Global CMC (GCMC) Regulatory Affairs organisation in the company is committed to support Biotherapeutic Pharmaceutical Science and Global Supply as a competitive advantage for the company by consistently delivering high quality regulatory strategies and timely submissions across the product lifecycle. GCMC is fully engaged in drug development, product line extensions and maintenance. GCMC representatives participate on teams and at sites as GCMC experts and advocate for effective drug development and maintenance paradigms.
We are currently seeking a high-calibre CMC regulatory professional to join our GCMC team in Grange Castle, Dublin. The role may support biologics, vaccines or other novel biotherapeutics and may be assigned to either post-approval and pre-approval CMC activities, or both.
Key responsibilities of the role include:
- Management of assigned CMC submission projects including development and optimisation of regulatory strategies; development of high quality submission content (Modules 2 and 3, IMPD); engagement with Boards of Health; and execution of major market and ROW submissions in accordance with plan
- Representation of GCMC effectively to stakeholders and customers for the assigned programs and products. Ensures that key product initiatives are progressed and participates in the resolution of issues that may impact product supply
- Playing an active role within the BioTx GCMC organization to advance regulatory intelligence through external engagement and to continuously improve systems and processes
Key qualities required for the role are:
- Knowledge of the technology underpinning Protein Biotherapeutics, vaccines, or other novel modalities (e.g. cell and gene therapy) including development, analytical and manufacturing technologies.
- Strong project management ability to execute high-quality, successful CMC submission projects with minimal supervision / oversight
- A demonstrated ability to achieve within a matrix, international network
- Ability to learn and navigate tracking / change control systems, compliant and consistent use of systems and willingness to train and support others in system use.
Education & Experience Requirements:
- Minimum BSc., MSc. or equivalent in a science related field
- An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (with 3-5 years’ experience in a relevant area).
Please send your CV through to us at firstname.lastname@example.org or call us on 01-456989