15 ene
Johnson & Johnson
Xico
Johnson & Johnson is currently recruiting a Senior Associate, Regulatory Affairs.
This position may be located in Mexico City, Mexico, or Panama City, Panama.
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.
**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.
- 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, SOPs, and work 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
- 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 in handling regulatory data on regulated products e.g.
OTC Drugs, Cosmetics, and Medical Devices
**Preferred**:
- Attention to detail with excellent documentation skills and the ability to continuously anticipate and solve problems
- Experience of 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**
Mexico-Distrito Federal-Mexico City
- **Other Locations**
Latin America-Panama-Panamá-Panamá
**Organization**
Johnson & Johnson, S.A. DE C.V. (8302)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206070915W
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