Senior Associate Cmc Regulatory

Johnson & Johnson is currently recruiting a Senior Associate CMC Regulatory.
This position may be located in São José dos Campos, Brazil; São Paulo, Brazil; Mexico City, Mexico; Skillman, NJ, USA; or Fort Washington, PA, USA.
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**:
This position will work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval.
Execute CMC regulatory strategies with internal research and development, and other technical/scientific colleagues.
Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings.
This position provides direction regarding the regulatory requirements of McNeil's new and marketed products, as well as helping support the implementation of long term companywide regulatory strategies and operating principles/practices.
May participate in the interviewing, hiring, and onboarding of new staff.
Performs other work-related duties and projects as assigned.
**Qualifications** Required**:
- A minimum of a bachelor's degree in a relevant health-related scientific discipline or preferably an advanced degree in a related field
- A minimum of 2 years of experience authoring and compiling all parts of Module 3 CMC sections
- A minimum of 2 years of consumer health industry experience
- Knowledge/familiarity with Brazil and Mexico's regulatory registration of drugs
- Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment
**Preferred**:
- Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems
- 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 seeking and incorporating stakeholder feedback
- Experience interacting with relevant trade associations or serving on trade association committees
- Experience interacting with health authorities
**Primary Location**
Mexico-Distrito Federal-Mexico City
- **Other Locations**
Latin America-Brazil-São Paulo, North America-United States-Pennsylvania-Fort Washington, United States-New Jersey-Skillman, Brazil-São Paulo-São José dos Campos
**Organization**
Johnson & Johnson, S.A. DE C.V
**Job Function**
Regulatory Affairs
**Requisition ID**
W