Manager, Regulatory Affairs
hace 5 días
**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
People Leader
**All Job Posting Locations**:
Bogotá Distrito Capital, Colombia
***:
**You will be responsible for**:
- Performing the preparation, submission, and maintenance of filings.
- Collaborating with senior department members to expedite commercialization of new technologies, new indications and line extensions.
- Providing early inputs to identify barriers and needs to craft global development plan.
- Interpreting local and international requirements.
- Providing support to cross-functional teams and representing the company in interactions with authorities and industry associations.
- Collaborating with teams of varied strengths to ensure alignment and consistency in strategies and submissions.
- As the Regulatory Affairs Manager, you will play a crucial role in making a significant impact on public health and contributing to the successful access of innovative therapies for the LA North population, being part of a team that values excellence, collaboration, and continuous learning.
**Qualifications - External**
- Education Required: Licenciatura or Bachelor's degree
- Experience Required: At least 6 years of experience. Strategic mindset & solid understanding of requirements and guidelines in the LA North region. Experience in leading submissions and interactions with regulatory authorities.
- Experience Preferred: Experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry. Ability to analyze information to develop effective scenario planning, leveraging differentiated strategies, solutions and opportunities for business growth. Actively manages customer needs and expectations. Capabilities to balance multiple projects simultaneously.
- Languages: Proficiency in English.
-
Contractor - Manager, Regulatory Affairs Latam
hace 5 días
Bogotá, Colombia Ultragenyx Pharmaceutical A tiempo completo**Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...
-
Regulatory Affairs Manager
hace 3 días
Bogotá, Colombia Reckitt A tiempo completoHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...
-
Regulatory Affairs Specialist
hace 7 días
Bogotá, Colombia Medtronic A tiempo completoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life**:The Regulatory Affairs Specialist supports the execution of regulatory strategies across...
-
Regulatory Affairs Specialist
hace 5 días
Bogotá, Cundinamarca, Colombia Solventum A tiempo completoJob Description: Regulatory Affairs Specialist, Colombia (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health,...
-
Senior Director of Medical Affairs
hace 1 día
Bogotá, Colombia Novo Nordisk A tiempo completoSenior Director of Medical Affairs & Regulatory Affairs **Category**:Clinical Development **Location**:Bogota, Cundinamarca, CO **The Position** - As Senior Director of Medical Affairs and Regulatory Affairs at Novo Nordisk, you will provide strategic leadership and ensure the alignment of medical and regulatory strategies with the organization’s goals....
-
Regulatory Affairs Specialist
hace 4 horas
Bogotá, Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Assoc Regulatory Affairs Spec
hace 7 días
Bogotá, Colombia Medtronic A tiempo completoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life**:The Associate Regulatory Affairs Specialist plays a key role in supporting global regulatory...
-
Regulatory Affairs Specialist
hace 1 día
Bogotá, Cundinamarca, Colombia CooperVision A tiempo completoCarrying out, controlling, and implementing activities related to the company's quality system. Carrying out, controlling, and implementing the regulatory processes applicable to the company's activities and products. Providing support to the RAQA manager in the department's activities. CooperVision is a global leader in the contact lens industry, dedicated...
-
Associate Regulatory Affairs Specialist
hace 7 días
Bogotá, Colombia Medtronic A tiempo completoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life**:Together, we can change healthcare worldwide. At Medtronic, we push the limits of what...
-
Regulatory Affairs Specialist
hace 1 día
Bogotá, Colombia IQVIA A tiempo completoBogotá, Colombia | Full time | Home-based | R1513810 **Job available in additional locations** **Job Overview** Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned...