Work with the department head to develop regulatory strategies for assigned projects across all phases of product development aimed at achieving marketing authorization and appropriate product labeling
Serve as regulatory representative on cross-functional teams and lead sub-teams to meet program objectives.
Plan, review and prepare INDs, NDAs and all related annual reports, amendments, supplements, and continued maintenance of approved marketed products
Primary point of contact for interfacing with Health Authority Regulatory Project Manager for assigned products
Lead cross-functional teams in the planning and execution of responses to regulatory authorities
Work with Regulatory Operations team to establish and meet timelines for regulatory submissions
Regularly report to management on progress against objectives and plans. Plan and direct projects and provide technical background, inspiration, and consultation to cross-functional colleagues as well as other members of the regulatory project team.
Keep abreast of and communicate changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions.
Support and participate in the development of Regulatory Department systems and processes
Other Regulatory Affairs duties as assigned or as business needs require
Bachelor’s degree in a science-related field such as Biology, Chemistry, or health-related major, with at least 7 years of experience in regulatory affairs in the pharmaceutical/biotech industry
Advanced degree preferred, but not required with 3+ years of experience
Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development
Experience with original IND, BLA or NDA in eCTD formatted submissions
Capable of strategic thinking and proposing innovative solutions to regulatory problems
Strong communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
Strong organizational, analytical, and time-management skills
Team-oriented leadership skills are essential
Internal Number: 7928203
About EPM Scientific
EPM Scientific is a leading specialist recruitment agency for the Life Sciences industry. We were founded in 2012 to give companies and candidates peace of mind that the recruitment process is in experts hands. Today, EPM Scientific provides permanent, contract, and multi-hire recruitment from our global hubs all over the world.
Finding the right people is rarely easy. It takes time, dedication and expertise. We have spent years building relationships with the top scientists, physicians, advisors, engineers and directors in the Life Sciences industry to create an exclusive network of potential candidates. We invest in best-in-class consultant training and innovative recruitment technology to handle the whole recruitment process, from source through to hire, with speed, precision and accuracy.
In the face of disruption, innovation and competition, Life Sciences companies and their leaders must find specialist talent faster than ever before. We want to reimagine recruitment for the better by offering a range of additional services to support our clients and candidates.