Regulatory Affairs Director
hace 6 días
**Job Description**:
Join our team and support us in our commitment to Invent for Life
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare helping provide new, reliable, and compliant medicines, practices and solutions to the world.
This position is a director level, sub-cluster Regulatory Affairs Lead for Central America and Caribbean Countries, Puerto Rico and Venezuela. The position is in charge and accountable for the entire regulatory activities in the sub-cluster above mentioned including strategy design, planning and execution of Pharmaceutical Products/Companion Diagnostics submissions, registration approvals and life cycle management in compliance with our company standards and local applicable regulations.
In addition, of obtaining the Marketing Authorizations and its maintenance, the position is in charge to facilitate broad communication with key internal and external stakeholders (Health Authorities, Distributors/Third Parties) to allow company products commercialization.
The Regulatory Affairs Director - Central America, Caribbean & Venezuela is the local point of contact within the company to regulatory authorities and local trade associations playing the regulatory policy role for the sub-cluster and pharmaceutical responsible in Panama.
**Requirements**:
- Bachelor's Degree ("Licenciatura") in Pharmacy. MBA, or Master's Degree, preferred.
- Ten (10) or more years of experience in Pharmaceutical Industry in Regulatory Affairs decision-making positions.
- Previous experience as a Regulatory Senior Manager or Director.
- Proficiency in English and Spanish, in oral and written.
- Willing to travel up 20% of the time.
**Who we are**
We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases.
**What we look for**
Here, you'll find rewarding opportunities, diverse experiences, and an unwavering commitment to ethics and integrity. You'll collaborate with a group of talented colleagues who share your sense of purpose. Our company will empower you to innovate, explore, and develop your full potential. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R200683
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