Position Summary

Experienced mid-level leadership position responsible for providing innovative solutions and regulatory submissions for all aspects of biologics development from discovery through post clearance maintenance. The position supports Regulatory Affairs by leading the coordination and preparation of regulatory premarket submissions under applicable sections of 21 CFR parts 3.2(e), 4, 210, 211, 600, 606, 610, 640 and 820.

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 biologic 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).
• Participate in SOP development and implementation.
• 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 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.
• Medical Device Regulatory Affairs experience and demonstrated leadership skills
• 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.