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About our client
Our client is a global biopharmaceutical company headquartered in MA that is dedicated to the development and commercialization of therapeutics for the treatment of anti infective diseases.The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate!
Position	Location
Director/Senior Director of Regulatory Affairs	Lexington, Massachusetts
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Lead the regulatory affairs liaison function 2) Ensure that the quality and content of submissions leads to successful and timely approval of regulatory applications 3) Lead regulatory strategy development and implementation 4) Advise on strategies necessary to optimize drug development programs 5) Author regulatory development plans for global registrations 6) Collaborate with partners to ensure successful global registration planning and implementation 7) Provide and/or guide strategic regulatory representation on Project teams 8) Communicate regulatory policy to internal customers and provide clarity on regulatory expectations (when needed) 9) Review/approve all regulatory submissions 10) Lead product labeling content development 11) Review final corporate drug development reports and regulatory submission documents for approval 12) Conduct regulatory due diligence on in-licensing and other external business opportunities 13) Lead the drafting, reviewing and administering of regulatory strategy and policy for client's licensed product(s) and throughout the drug development process on development candidates 14) Liaise (effectively), negotiate and partner with all global regulatory authorities 15) Lead regulatory interactions with global regulatory authorities 16) Mentor and lead the staff
Requirements
1) Advanced degree in the Physical/Life or Medical Sciences preferred 2) Minimum 8 years of relevant experience in the development of drugs or biologics 3) Regulatory experience in supporting both development projects and marketed products 4) In-depth understanding of US as well as international drug and biologics guidelines and regulations 5) Ability to delegate effectively for execution 6) Proficiency in computers 7) Ability to work independently and within a team setting 8) Excellent communication and presentation skills