Job title: Senior Associate, Regulatory Affairs (New Consumer Health Company)
Company: Johnson & Johnson
Job description: Job Description:
Johnson & Johnson is currently recruiting a Senior Associate, Regulatory Affairs. This position is located in Mumbai, India.
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 innovative ideas, products and services to advance the health and well-being of people.
With $82.1 billion in 2020 sales, Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world’s most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world’s most pressing health issues.
Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.
It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.
Role & Responsibilities:
The Senior Associate, Regulatory Affairs works with supervision and has responsibility for supporting a large portfolio of products, areas of the business, or function.
Interacts with regulatory agency personnel in order to seek guidance, expedite approval of pending applications, and resolve regulatory matters
Works with supervision to plan, conduct, and manage regulatory activities to meet department and company objectives
Sophisticated knowledge of current regulations in a specified area, with sufficient experience and skill to execute under general supervision
Ensures compliance within the department by ensuring global, regional, and local processes, policies, SOP,s and working instructions are adhered to
Updates relevant global, regional and local databases to ensure compliance
Prepares and compiles routine regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines
Develops, translates (if relevant), reviews and approves artwork and promotional copy material to ensure regulatory compliance
Develops timelines for submissions and monitors progress of applications against set timelines, taking action where necessary to minimize delays and anticipate difficulties
Communicates information and presents status updates on product/project activities to key internal/external stakeholders
Provides input to regulatory strategies
May represent J&J and provide regulatory advice at e.g. joint company/trade association initiatives, regulatory agency meetings etc. (as appropriate)
Assists in the development of best practices for Regulatory Affairs processes
Provides solutions to a variety of problems of moderate scope and complexity
Maintains and archives regulatory documentation (as appropriate)
Organizes and maintains reporting schedules
Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
Ensures quality and compliance in all actions
Qualifications
Required:
Degree in Life Sciences or equivalent combination of training and experience, with at least 5 years of proven experience in Regulatory Affairs
Experience of handling regulatory data on regulated products e.g. OTC Drugs, Cosmetics and Medical Devices
Excellent computer skills in Word, Excel, PowerPoint, Email, and Internet
Preferred:
Attention to detail with excellent documentation skills and the ability to continuously anticipate and solve problems
Experience in Regulatory processes such as Drug Listing, IDMP, and Periodic Safety Reporting
Strong and effective interpersonal skills, with a team-oriented and collaborative approach geared towards providing solutions and consistent delivery
Ability to multi-task and deliver high-quality work under pressure to deliver results
Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans and strong track record of seeking and incorporating stakeholder feedback
Primary Location
India-Maharashtra-Greater Mumbai-
Organization
Johnson & Johnson Private Limited (8080)
Job Function
Regulatory Affairs
Requisition ID
2206070917W
Expected salary:
Location: Mumbai, Maharashtra
Job date: Fri, 02 Sep 2022 04:13:03 GMT
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