Oncology Regulatory Affairs Manager
Share
Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Bogotá Distrito Capital Colombia Mexico City Mexico São Paulo BrazilJob Description:
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at are searching for the best talent for a Oncology Regulatory Affairs Manager position based in São Paulo Bogotá or Mexico City.
Purpose: Regulatory Affairs Manager for the Latin America region being responsible for the regulatory science and crafting the strategies to advance projects for early stages of research and develop submissions and approvals for initial marketing authorization applications and lifecycle managements of the products assigned.
This role involves:
Working closely with local global and other cross-functional partners to ensure compliance with requirements and the outstanding strategies for the assets in the market.
Performing the preparation submission and maintenance of filings.
Collaborates with senior department members to expedite commercialization of new technologies new indications and line extensions.
Provides early inputs to identify barriers and needs to craft global development plan.
Interpreting local and international requirements.
Additionally provides support to cross-functional teams and represents the company in interactions with authorities and industry associations.
Collaborate with teams with varied strengths to ensure alignment and consistency in strategies and submissions.
Qualifications
Bachelors degree completed
Proven ability in regulatory affairs focusing on the pharmaceutical or biotechnology industry keeping abreast with trends developments technologies and competitive landscape within the health care and pharmaceutical field.
Solid understanding of requirements and guidelines in the Latin America region is needed.
Be able to analyze information to develop effective scenario planning. Uses this information to prioritize those scenarios and respond proactively to customer needs and to further the companys strategy.
Confirmed experience in leading submissions and interactions with regulatory authorities.
Excellent communication and interpersonal skills with the ability to work optimally in a cross-functional environment.
Be able to work independently and balance multiple projects simultaneously.
Proficiency in English and Spanish is required and proficiency in Portuguese is a plus.
Required Skills:
Preferred Skills:
Analytical Reasoning Business Writing Coaching Fact-Based Decision Making Industry Analysis Legal Support Process Improvements Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Risk Compliance Strategic Thinking Technical CredibilityRequired Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
