12 days ago
About Your New Employer
- Clinical stage biopharmaceutical company dedicated to discovery, development and commercialisation of biotheraputics focused on the treatment of cancer.
- You will be based in a state-of-the-art site which is a strategic facility in the global network
About Your New Job
- The Associate Director of Regulatory Affairs will be tasked with developing strategies and overseeing the preparation of global regulatory submissions including clinical trails applications, their amendments, and other regulatory documents including orphan drug applications and Paediatric Investigation Plans (PIP).
- You will Lead clinical trial applications (CTAs) as well as EU Marketing Authorisation Applications (MAA)
- Coordinate and manage responses to Regulatory Agency queries in a timely manner.
- Act as the sponsor contact with Health Authorities
- Prepare documents for and lead Regulatory Agency interactions.
- Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure execution of the regulatory strategy.
- You will be tasked with developing and implementing regulatory strategies to meet project deliverables and mitigate potential regulatory risks.
- Contribute to establishing department processes and participate in SOP and other process development.
- Work with development partners.
What Skills You Need
- Minimum 7 years of relevant industry experience in with drug or therapeutic biologic products. Experience in oncology strongly preferred.
- Strong outsourcing track record.
- Well experienced with monoclonal antibodies.
- BS in a life sciences discipline; advanced degree preferred but not required.
- Experience in the preparation of regulatory documentation to support CTAs, MAAs; oversight of CROs or contractors.
- Requires knowledge of global health authority regulations and guidelines with a focus on EU, UK, and ICH
- Strong technical/analytical skills to identify and solve problems independently.
- Proven ability to manage multiple projects, identify and resolve regulatory issues.
- Excellent organizational skills, able to work on a number of projects under tight timelines.
- Excellent verbal and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Ability to work independently with minimal supervision or direction.
What’s on Offer
- Permanent position with a competitive salary.
- Annual Bonus.
- Career progression opportunities.
- Travel opportunities.
- Apply now by clicking the “Apply Now" button or call me, Ben Byrne on +353 1 4744688.
- Or if the job isn’t quite right but you are looking for something similar, please get in touch
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