Director, Regulatory Affairs - Biologics

Position Summary

The Director, Regulatory Affairs will oversee and direct all global (including U.S.) regulatory support and submissions for early to late-stage development (and commercial) biologics products. Responsible for developing and implementing innovative biologics regulatory strategies and the preparation and submission of high-quality Biologics INDs, BLAs and other device related submissions. Subsequent supplements and variations will be developed in close collaboration with in-house Clinical Operations, Manufacturing and Supply Chain and Quality teams, contract manufacturing organizations, external experts, collaborators, and strategic partners.  Liaise with regulatory authorities via written/verbal communication and lead meetings. Maintain a high-level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy.

Principal Responsibilities

•    Actively retain and drive talent development through coaching, mentoring, development assignments and other formal / informal actions and systems.
•    Develop a vision and strategy which inspires the team and drives towards the business needs.
•    Lead product focused team of Regulatory professionals, utilizing strong technical regulatory skills in developing strategies for complex projects and issues.
•    Constantly delivers improved value for all stake holders by driving and developing a culture of excellence through continuous improvement.
•    Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for product(s) and ensure alignment with our overall business strategy. 
•    Management and oversight of creation, of eCTDs for biologic product submission to US and outside-US Health Authorities.
•    Manage communication with regulatory agencies, such as managing on site/remote meetings, participating in regulatory inspections, and representing the company as required.
•    Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
•    Proactively support multidisciplinary product development teams and communicate regulatory requirements effectively.
•    Provide regulatory input to product lifecycle planning.
•    Develop strong regulatory strategies in alignment with commercial and clinical needs.
•    Determine issues which may create regulatory obstacles and investigate solutions to address these issues.  
•    Support clinical evidence and claims development.
•    Evaluate regulatory impact and support design transfer(s) and manufacturing changes.
•    Support review and approval of Labeling (product, advertising and promotional).
•    Maintain regulatory files as required by procedure.
•    Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor’s Degree in engineering, medical, science or related field required.  Master’s degree preferred.  
•    7 to 10 years of overall Medical Device Regulatory Affairs experience with demonstrated leadership skills. 
•    Hands-on experience in the pharmaceutical (drug and/or biologic) industry required, including but not limited to management and authorship of eCTD filings for INDs, BLAs and NDAs; regulatory strategy development, risk management, and change control participation.
•    In-depth working knowledge of FDA sections of 21 CFR parts 3.2(e), 4, 210, 211, 600, 606, 610, 640, 820.20, 820.30, 820.50 and 820.100 and precedents relevant to Teleflex products. 
•    Documented direct interface with Health Authorities via multiple modes (face-to-face, T-con, and emails).
•    Experience in working with government contracts and requirements is an advantage in this role.
•    RAC certification, preferred. 
 

Specialized Skills / Other Requirements

•    Ability to apply business and Regulatory Affairs ethical standards. 
•    Excellent analytical and critical thinking skills.
•    Able to travel domestically and internationally.
•    Diplomacy and negotiation skills, as well as the confidence to take unpopular decisions.
•    Demonstrated skills in leadership and development of people and teams. 
•    Capability to build and maintain effective working relationships across functions and organizations and levels.  
•    Demonstrated effectiveness with interpersonal skills and the ability to interface with cross functional teams and leadership.  
•    Demonstrated expertise in planning, budgeting, personnel development, and project management directed toward achievement of annual, long term and strategic business plans and goals.  
#LI-AD1