Regulatory Affairs Expert
hace 1 semana
As a key member of our team at MSD, you will be responsible for providing centralized oversight of regulatory activities defined by global, regional, and local contracts and arrangements. This role requires minimal guidance from the Director of Business Development Execution.
Key Responsibilities:- Centralized oversight of regulatory activities
- Oversight and maintenance of tools to enable efficient operations for the Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution and GRACS Integration teams
- Point of contact for all alliance management issues, including contractual questions related to ongoing GRACS activities
This role also involves leading execution and support of ancillary agreement activities, such as divestitures and terminations. You will work closely with Corporate Business Development, Research & Development Division Global Alliance Management (MGAM), and GRACS Business Development to comprehend partner agreements and goals.
RequirementsTo be successful in this role, you will require a strong understanding of regulatory and clinical processes for pharmaceutical products, vaccines, and/or biologic products. Additionally, you should have working knowledge of regulatory concepts, requirements, and overall product lifecycle processes.
-
Regulatory Affairs Expert
hace 7 días
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completo**Job Description**We are seeking a skilled Regulatory Affairs Specialist to join our team at AbbVie. As a key member of our regulatory affairs department, you will play a critical role in ensuring the development and approval of our pharmaceutical products.Your primary function will be to serve as a subject matter expert (SME) for regulatory dossiers,...
-
Regulatory Affairs Expert
hace 5 días
Bogotá, Bogotá D.E., Colombia Allergan Aesthetics A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Allergan Aesthetics. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance and accuracy of regulatory documents and processes.Preparation of high-quality regulatory dossiers in accordance with product regulatory...
-
Regulatory Affairs Expert
hace 5 días
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completo**Job Summary**We are seeking a highly skilled Regulatory Affairs Expert to join our team at Allergan. In this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with local and global regulations.As a key member of our regulatory team, you will work closely with cross-functional groups to prepare and...
-
Regulatory Affairs Manager
hace 22 horas
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completoJob DescriptionThe Regulatory Affairs Manager will lead the execution of regulatory strategies for AbbVie's portfolio, ensuring compliance with regulatory requirements and delivering high-quality regulatory submissions.You will work closely with cross-functional teams to develop and implement regulatory strategies, and provide expert guidance on regulatory...
-
Regulatory Affairs Professional
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completoAbout the RoleAs a Regulatory Affairs Specialist at Allergan, you will play a vital role in ensuring compliance with regulatory requirements and implementing strategies to achieve first-pass approval from health authorities. Your expertise as a subject matter expert will be instrumental in preparing state-of-the-art regulatory dossiers that meet product...
-
Regulatory Affairs Director
hace 5 días
Bogotá, Bogotá D.E., Colombia Johnson & Johnson A tiempo completo**Job Overview**We are seeking a highly skilled Regulatory Affairs Manager to join our team in Latin America. As a key member of our Regulatory Affairs Group, you will be responsible for preparing, submitting, and maintaining filings with regulatory authorities.Your expertise in regulatory affairs will play a crucial role in expediting the commercialization...
-
Regulatory Affairs Manager
hace 7 horas
Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completoAbout the PositionWe are looking for a Regulatory Affairs Manager to oversee the quality assurance programs and policies at Medtronic.You will facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally.A fluency in German is required, and one year of experience working with...
-
Regulatory Affairs Strategist
hace 2 días
Bogotá, Bogotá D.E., Colombia Allergan Aesthetics A tiempo completoJob Description:As a Regulatory Affairs Specialist at AbbVie, you will play a crucial role in ensuring the company's compliance with regulatory requirements. Your primary responsibility will be to develop and maintain regulatory dossiers that meet the highest standards of quality and accuracy.Main Responsibilities:Preparation of state-of-the-art regulatory...
-
Regulatory Affairs Director
hace 2 días
Bogotá, Bogotá D.E., Colombia Allergan Aesthetics A tiempo completoAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at AbbVie. As a member of our regulatory affairs department, you will be responsible for developing and maintaining regulatory dossiers that meet the highest standards of quality and accuracy. Your primary responsibility will be to put in place strategic visions...
-
Bogotá, Bogotá D.E., Colombia Biospifar S.A. A tiempo completoJob OverviewBiospifar S.A. is seeking a highly skilled Technical Director/Regulatory Affairs Manager to lead our regulatory strategies and ensure sanitary compliance in Colombia.This role will be responsible for developing and executing regulatory plans, managing relationships with regulatory agencies, and ensuring the quality and regulatory integrity of our...
-
Regulatory Affairs Expert
hace 5 días
Bogotá, Bogotá D.E., Colombia Bitfinex A tiempo completoAbout BitfinexBitfinex is a digital asset trading platform that has been pioneering state-of-the-art services for digital currency traders and global liquidity providers since its inception in 2012. As a company at the forefront of financial evolution, we are committed to creating innovative solutions that drive the industry forward.Regulatory Affairs...
-
Global Regulatory Affairs Expert
hace 6 días
Bogotá, Bogotá D.E., Colombia Johnson & Johnson A tiempo completoJob OverviewWe are committed to making a world where complex diseases are prevented, treated, and cured. Our Innovative Medicine and MedTech expertise empowers us to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.Key ResponsibilitiesPrepare and submit regulatory filings in accordance with local and...
-
Regulatory Affairs Expert
hace 1 día
Bogotá, Bogotá D.E., Colombia Johnson And Johnson A tiempo completoJob DescriptionAt Johnson & Johnson, we are committed to harnessing the power of innovation to make a meaningful difference in people's lives. Our goal is to develop and deliver solutions that improve health outcomes and address some of the world's most pressing healthcare challenges.This role will play a critical part in our success by providing strategic...
-
Regulatory Affairs Leader
hace 3 días
Bogotá, Bogotá D.E., Colombia J&J Family Of Companies A tiempo completoJob Description:About Our TeamAs a Regulatory Affairs Manager at J&J Family Of Companies, you will be part of a team that values excellence, collaboration, and continuous learning. We believe health is everything and are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.Your Key...
-
Regulatory Affairs Professional
hace 1 semana
Bogotá, Bogotá D.E., Colombia Allergan Aesthetics A tiempo completoAt Allergan Aesthetics, we are committed to discovering and delivering innovative medicines and solutions that solve serious health issues. As a Regulatory Affairs Specialist, you will play a key role in developing and implementing regulatory strategies to ensure the safe and effective use of our products.Key Responsibilities:Develop and maintain regulatory...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia IQVIA A tiempo completoJob SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support the preparation of study reports, submissions, and other documents for internal customers or external clients.Key ResponsibilitiesSupports publishers in the compilation, publishing, and quality control review of regulatory submissions.Collects and...
-
Regulatory Affairs Specialist
hace 1 semana
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completoCompany Overview At Allergan, we are dedicated to delivering innovative medicines and solutions that improve people's lives. Our mission is to be a leader in the development of groundbreaking treatments for various health issues. We strive to make a remarkable impact across multiple therapeutic areas, including immunology, oncology, neuroscience, and eye...
-
Regulatory Affairs Specialist
hace 3 días
Bogotá, Bogotá D.E., Colombia Allergan Aesthetics A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Allergan Aesthetics. This role will be responsible for ensuring the inclusion of the latest regulatory framework in all product submissions, leading to timely Marketing authorization.The ideal candidate will have a strong understanding of regulatory compliance...
-
Strategic Regulatory Expert
hace 2 días
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completoJob Summary">We are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for providing strategic regulatory expertise to support the development and approval of new products. This includes developing regulatory dossiers, influencing the regulatory environment, and ensuring compliance with local...
-
Regulatory Affairs Specialist
hace 2 días
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completoOverviewAllergan, a leading innovator in the pharmaceutical industry, is seeking a highly skilled Regulatory Affairs Specialist to join our team. In this critical role, you will play a key part in shaping the regulatory strategy for our products and ensuring compliance with local regulations.Key Responsibilities:Develop and maintain comprehensive regulatory...