Regulatory Affairs Specialist
hace 5 horas
We are seeking a skilled Regulatory Affairs Manager to join our team at Johnson & Johnson in Mexico City, MX; Mendoza, AR; Bogotá, CO or São Paulo, BR. This role will be responsible for the preparation, submission, and maintenance of filings.
Key Responsibilities:
• Collaborate with senior department members to expedite commercialization of new technologies, new indications and line extensions.
• Provide early inputs to identify barriers and needs to craft global development plan.
• Interpret local and international requirements.
• Provide support to cross-functional teams and represent the company in interactions with authorities and industry associations.
• Collaborate with teams of varied strengths to ensure alignment and consistency in strategies and submissions.
Qualifications:
• Licenciatura or Bachelor's degree in a relevant field.
• At least 6 years of experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry.
• Strategic mindset and solid understanding of requirements and guidelines in the Latin America region.
• Experience in leading submissions and interactions with regulatory authorities.
• Proficiency in English, and proficiency in Portuguese and Spanish is a plus.
This position may require up to 10% travel.
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