Head of Regulatory Affairs
Company: Johnson & Johnson
Location: Jacksonville, Florida
Posted: March 01, 2017
Reference ID: 6824170119-en-us
Johnson & Johnson Vision Care, Inc. is recruiting for a Head of Regulatory Affairs. The position will be based in Santa Ana, CA.
Johnson & Johnson Vision Care, Inc. is the world’s leading innovator and manufacturer of disposable contact lenses. The company has long set industry standards through groundbreaking technologies and products. The best-selling ACUVUE® Brand Contact Lenses launched as the world’s first mass-marketed disposable soft contact lens in 1987, and since then the brand has introduced numerous first-to-market products. Johnson & Johnson Vision Care, Inc. has continued its track record of growth and innovation. The company has a robust new product pipeline and clinical agenda that have translated into a wide range of novel solutions to meet patient needs. A quarter of a century after revolutionizing the contact lens industry with the introduction of the first disposable soft contact lens, Johnson & Johnson Vision Care, Inc. continues its course to bring healthy vision to everyone, everywhere, every day through new technologies and innovative products.
The Head of Regulatory Affairs responsibilities include:
• Responsible for directing both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, regional re-registrations, copy clearance, global LCM labeling support, and external environment surveillance).
• Oversees the creation of global regulatory product development strategies and preparation/submission of marketing approval applications to health authorities in order to ensure that development plans meet global regulatory requirements.
• Interacts with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business.
• Responsible for providing direction and leadership to the Regulatory staff while also building necessary relationships with regional regulatory colleagues and fostering opportunities with the broader Enterprise regulatory communities to facilitate more efficient support of both growth/innovation and post-marketing LCM Regulatory initiatives worldwide.
• Defines the strategic regulatory direction for pipeline development and global launch excellence and responsible for regulatory aspects of lifecycle management.
• Ensures aligned and coordinated contact and communication with global and regional/local regulatory agencies.
• Exercises highly complex level of independent judgment and execution directly impacting the operational results of the business.
• Monitors the regulatory environment globally and provides assessments of the impact of new and changing regulations on the company’s programs.
• Manages, oversees, and balances resource allocation across critical projects.
• Implements department or division strategies and serves as an authority to the business.
• Identifies and manages risks and business needs and develops initiatives to optimize internal customer/key stakeholder value.
• Ensures the development and implementation of leading edge systems and practices internally/across sites/companies.
• Removes barriers and serves as a change agent for global effectiveness.
• Provides project leadership or participates as a team member on major initiatives that have high impact to the business.
• Key member of the leadership team.
• Applies influence across departments and the business.
• Accountable for organizational depth to meet present and future business needs, looking across J&J companies.
• Demonstrates the ability to foster long-term learning and develops Regulatory staff to become future leaders.
• Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements.
• Adheres to environmental policy and procedures and supports department environmental objectives.
• A minimum of a Bachelor’s Degree in a scientific or technical related discipline is required.
• An advanced degree is preferred (MS, MBA, PhD, MD, etc.).
• A minimum of 10 years of working experience in Regulatory Affairs in a relevant/regulated industry is required.
• Medical Device industry experience is strongly preferred.
• Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required.
• Senior leadership experience, including line management of multiple levels of reporting is required.
• Expert knowledge, understanding, and application of principles, concepts and practice of worldwide health authority regulations is required.
• Excellent organizational, communication, negotiation and interpersonal skills is required.
• Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met is required.
• Experience working with professional and trade associations is a plus.
• This position will be located in Santa Ana, CA. and will require approximately 20% travel, domestic and international.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Johnson & Johnson Vision Care, Inc. (6094)