Reference Number: JO-2109-476418
Associate Director/Director, Regulatory Affairs
Job Type: Permanent
Location: United States
Director, Regulatory Affairs
Negotiable Base Salary
+ Bonus & Stock Options
Are you an ambitious Director of Regulatory Affairs looking to work for a highly successful business that recognizes and rewards it’s people whilst offering a great platform for your future career development?
If so, look no further! This is the perfect opportunity to join a well-funded and strategically sound business entering a very exciting period of growth and with a strong pipeline of development. Having just filed their first BLA, you will play a pivotal role in shaping the regulatory strategy and driving forward a number of new programs that will help bring high quality and affordable therapies to patients.
- Support clinical and commercial oncology products, implementing regulatory strategy and plans.
- Act as the regulatory lead for oncology project teams, sub teams and submission teams to effectively contribute towards regulatory submissions, protocols, brochures, post approval supplements, type C and change control.
- Provide support to commercial teams on post approval supplements, line extensions and regulatory filings in support of commercial products and post-marketing commitments within the US and EU.
- Ensure submissions are complete, well-organized and compliant and liaise with SME’s, external vendors and regulatory operations. Undertakes proofreading in support of final regulatory submissions.
- Provide regulatory intelligence and research to support regulatory and oncology clinical development.
- Undertake post-marketing activities including review and approval of labeling, advertising and promotional materials.
- Analyzes and advises on complex regulatory guidance documents, regulations or directives that could impact the business and promotion of products.
Qualifications & Experience:
- A minimum of 4-years’ experience within regulatory affairs and at least 7-years biopharmaceutical industry experience .
- Qualified to a minimum of Bachelor’s degree with an advanced degree preferred.
- Regulatory experience gained within Biologics.
- Oncology or Immuno-oncology experience would be a major advantage.
- Experience gained across all phases of development (Pre-IND, IND, NDA, BLA through to post launch/marketing)
- Expertise with electronic submission requirements and review of promotional materials for regulatory filings.
- Able to demonstrate a sound understanding of government guidelines and regulations, particularly FDA, ICH and GXP.
- Experience in establishing and managing regulatory intelligence through search evaluation and distillation of regulatory and clinical data sources.
To be considered please apply or contact Gary.Crawley@cpl.com for further information.