Manager, Regulatory Affairs- Biomaterials

Johnson & Johnson Innovative Medicine•West Chester, PA

1d•$117,000 - $201,250

About The Position

The Manager, Regulatory Affairs – Biomaterials External Innovation develops and executes regulatory strategies for biomaterials, biologics, combination products, and externally sourced innovation opportunities. Working with cross-functional teams and external partners, the role provides early-stage regulatory guidance, supports due diligence and business development, and advances product development, clinical programs, regulatory submissions and approvals, launch readiness, and lifecycle management. The position applies specialized expertise in Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practice (CGMP), Biologics License Applications (BLA), and Investigational Device Exemptions (IDE) to support compliant decisions and commercialization in key markets. The manager leads regulatory activities for assigned programs and portfolios, sets priorities, communicates risks and recommendations, and coordinates regulatory engagement and deliverables across internal teams, external partners, and regulatory agencies. The role also leads regulatory screening and technical due diligence for biomaterials external innovation, partnerships, licensing, acquisitions, and other business development opportunities. It provides technical guidance and training to colleagues and cross-functional partners, supports regulatory capability planning, and promotes accountable, collaborative execution. The position is based in West Chester, Pennsylvania, or Raynham, Massachusetts. The anticipated base pay range is $117,000 to $201,250. Employees are eligible to participate in the company’s pension and 401(k) savings plans and long-term incentive program, subject to plan terms. Listed time-off benefits include vacation, sick time, holidays and floating holidays, work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off. Following the anticipated separation of the Orthopaedics business, the employee is expected to become an employee of DePuy Synthes, subject to completion of the transaction and applicable conditions.

Requirements

Bachelor’s degree or higher in a scientific, engineering, pharmacy, or other relevant technical discipline.
At least 8 years of relevant experience in the medical device, biologics, pharmaceutical, combination-product, or other regulated healthcare industry, including experience supporting complex product development programs.
Specialized regulatory expertise in CMC and CGMP requirements.
Experience developing and executing regulatory strategies aligned with business objectives.
Required skills include biologics and combination-product regulatory strategy, regulatory submissions, early-stage regulatory strategy, external innovation assessment, regulatory due diligence, cross-functional collaboration, and clear written and verbal communication.
Ability to exercise independent judgment on complex regulatory issues and identify key risks and evidence requirements.
Ability to partner with and influence stakeholders at senior levels and lead through influence.

Nice To Haves

Advanced degree.
Direct experience with BLA and IDE development, submission, or lifecycle support.
Experience assessing early-stage external innovation, conducting regulatory due diligence, and supporting external partnerships or business development opportunities.
Biomaterials and regenerative medicine experience.
External partnerships and business development experience.
Global regulatory strategy experience.
Experience with PMA, De Novo, 510(k), and technical documentation.
Compliance risk, fact-based decision-making, continuous improvement, developing others, inclusive leadership, innovation, and strategic thinking.

Responsibilities

Lead regulatory activities supporting development, submissions, approvals, and lifecycle management of biomaterials, biologics, combination products, and medical devices before global regulatory authorities.
Develop risk-based regulatory strategies to enable timely product development and commercialization.
Manage assigned Regulatory Affairs activities, establish priorities, and communicate regulatory objectives, risks, and recommendations to project teams and business leaders.
Lead preparation and maintenance of regulatory submissions and files, including BLAs, IDEs and IDE Supplements, PMAs and PMA Supplements, 510(k)s, De Novo requests, HDEs, annual reports, global change notifications, and technical documentation, as applicable.
Define and execute regulatory strategies for pipeline development, clinical programs, and global launch readiness, particularly for Biomaterials External Innovation opportunities.
Partner with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Commercial, Business Development, and other stakeholders to evaluate opportunities and implement regulatory strategies.
Exercise independent judgment on complex regulatory issues, identify risks and evidence requirements, and drive regulatory deliverables across projects and external partnerships.
Provide day-to-day leadership, coaching, and technical guidance to Regulatory Affairs colleagues and cross-functional project teams, as applicable.
Develop and deliver training on current and emerging regulatory, CMC, CGMP, biologics, combination-product, and clinical investigation requirements.
Ensure aligned and coordinated contact and communication with global and regional or local regulatory agencies.
Ensure company policies, procedures, and practices comply with applicable regulatory requirements.
Support timely regulatory approvals and clearances, identify capability gaps, propose solutions, and implement plans aligned with organizational and Regulatory Affairs objectives.
Communicate a clear regulatory vision and foster accountability, collaboration, and effective execution across internal teams and external partners.
Lead Regulatory Affairs screening and technical due diligence for Biomaterials External Innovation, external partnerships, licensing, acquisition, and other business development opportunities; develop early-stage assessments, identify risks and evidence needs, and recommend development pathways.
Represent the Biomaterials External Innovation regulatory perspective in governance forums, partner interactions, diligence activities, and regulatory agency engagements.
Cultivate relationships with regulators in key markets and collaborate internally with R&D, Medical Affairs, Clinical Affairs, GSM, and other partners.
Anticipate and influence regulatory changes in key markets to maximize patient access to innovative technologies.
Coordinate accountable cross-functional teams and external partners to achieve timely, high-quality regulatory outcomes while balancing strategic and near-term priorities.
Apply specialized expertise in biologics, biomaterials, combination products, CMC, CGMP, BLA, and IDE requirements to guide development planning, risk mitigation, submissions, and lifecycle activities.
Promote innovative thinking, informed risk-taking, intellectual curiosity, and continuous learning.
Educate and coach others on business plans and Regulatory Affairs strategies, and advise and challenge business partners to support sound decisions.

Benefits

Pension plan.
401(k) savings plan.
Long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for residents of Colorado and Washington.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.