Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.
The senior manager, Regulatory Affairs India, Sri Lanka & Bangladesh is responsible for all aspects of regulatory responsibilities in India, Sri Lanka & Bangladesh. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured, or distributed to meet all the required legislations in all applicable markets.
Additionally, this role is responsible for directing 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).
- o The senior manager will be a member of both India Surgical Vision Leadership Team and India Vision Care Leadership Team.
- o The senior manager will develop, actively mentor and supervise a team of regulatory professionals in India, Sri Lanka & Bangladesh.
- o This role has market & business level influence and responsibility and is considered a key opinion leader and an expert resource both within JJV and externally on all regulatory matters across the region.
- o This senior manager will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information.
- Directs both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, renewals, 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 to ensure that development plans meet global regulatory requirements.
- Ensure compliance with product post-marketing approval requirements. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- 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. Participate in applicable trade association/industry working groups to influence policy in alignment with business strategies.
- Identifies and manages risks and business needs. Ensures the development and implementation of leading-edge systems and practices internally/across sites/companies. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
- Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership or participates as a team member on major initiatives that have high impact to the business. Key member of leadership team. Applies influence across departments and the business.
- Anticipate emerging issues and develop solutions.
- Prepare and manage the budget (OOS/FTE) for department.
- University degree (Bachelor’s degree or relevant)
Experience and Skills:
- 8-12 years of relevant experience
- Expert knowledge, understanding, and application of principles, concepts, and practice of regional governmental regulations.
- Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
- Excellent organizational, communication, negotiation, and interpersonal skills.
- Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.
Are you ready to impact the world?
Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.