Associate Director CMC Reg Affairs
This innovative healthcare organisation is a leader in the industry with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, this leader is building a new kind of healthcare company – one that is ready to help create a healthier future for all. With revenues north of 40B per annum and employing upwards of 70,000 staff globally, this organisation is committed to supplying next generation pharmaceutical products for life threathening diseases to over 100 countries globally. As a result of continued growth, a new requirement has arisen for an Associate Director of CMC Reg Affairs to be based at their start of the art manufacturing facility in the South of Ireland.
- Regulatory point of contact between site and corporate Regulatory personnel, for clinical and commercial small molecules and helping to define site Regulatory strategy.
- Support Corporate Regulatory personnel with the preparation of new filings and maintenance of dossiers.
- Provide regulatory leadership and 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.
- Correspondence and interaction with Global CMC affiliates and other scientists to support either new or in line product filings worldwide.
- 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.
- Review site technical reports when complete from Regulatory perspective – (for reports that could be used to support global Regulatory filings).
- Review site change control to provide pre-read on impact to Clinical / commercial licences for proposed changes.
- Min 5 Years’ experience in the pharmaceutical industry within a regulatory affairs role.
- Direct Experience with regulatory submissions desirable.
- BSc in a Science related subject.
- Strong knowledge of regulatory and compliance guidelines within the pharmaceutical manufacturing.
- CMC experience is highly desirable
To learn more apply on line or call Shane Browne on +353 1 6321865
Salary: On Application