Regulatory Affairs Consultant
hace 7 meses
**Accountability / Scope**
- As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration.
- Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions.
**Major Responsibilities**:
- Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, and amendments.
- Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes.
- Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
- Participates/ Awareness on project plans, regulatory submission strategy, any risks management.
- Partner with other regulatory functions for smooth project transition and launch.
- Support review of change controls to determine the level of modifications and consequent submission requirements.
- Support pulling reports, metrics related to submissions and approvals.
- Offers country specific regulatory support (INVIVA).
**Requirements Include**:
- Prior experience (3-4yrs) and bachelor’s degree in health care or science.
- Good English skills.
- Experience with Veeva Vault, not mandatory.
- Good understanding and working experience in different regulatory environment in Colombia.
- Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
- Adaptable in cultural and political diversity.
- Capacity to learn and challenge status quo.
LI-REMOTE
Back to nav
-
Senior Regulatory Affairs Specialist
hace 7 meses
Desde casa, Colombia Thermo Fisher Scientific A tiempo completoWe are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and...
-
Principal Regulatory Affairs Specialist
hace 5 días
Desde casa, Colombia Thermo Fisher Scientific A tiempo completoWe are currently seeking a Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating...
-
Senior Reg Affairs Specialist
hace 7 meses
Desde casa, Colombia Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Sr Reg Affairs Spec
hace 7 meses
Desde casa, Colombia Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Sr Reg Affairs Spec
hace 7 meses
Desde casa, Colombia Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
-
Regulatory Affairs Associate
hace 3 horas
Desde casa, Colombia Parexel A tiempo completoAs part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...
-
Regulatory Affairs Associate
hace 7 meses
Desde casa, Colombia Parexel A tiempo completoColombia, Remote **Job ID** R0000002443 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: An Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. An Associate must be technically competent and continually developing the skills as...
-
Regulatory Affairs Associate
hace 2 semanas
Desde casa, Colombia Parexel A tiempo completoAs part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...
-
Clinical Evaluation Report Medical Writer
hace 1 día
Desde casa, Colombia Criterion Edge A tiempo completo**Clinical Evaluation Report Medical Writer** **Job Type**:Part-Time, Contractor, Fully Remote Position **Experience Level**: Experienced Criterion Edge (CE) is seeking a remote contractor for the Clinical Evaluation Report (CER) Regulatory Writer role. The position is responsible for providing regulatory writing expertise for the development of initial...
-
Commercial Lending Operations Counsel
hace 7 meses
Desde casa, Colombia World Business Lenders, LLC A tiempo completo**Description** World Business Lenders (WBL) provides general purpose short-term real estate collateralized commercial loans to a broad customer base comprised of small and medium sized businesses throughout the United States that lack access to traditional funding. This is a Contract/Consultant position. Generally, working hours will be 9:00am-6:00pm...
-
Fast Consultant
hace 8 meses
Desde casa, Colombia Transamerica A tiempo completoJob Family Internal Sales - About Us At Transamerica, hard work, innovative thinking, and personal accountability are qualities we honor and reward. We understand the potential unleashed by leveraging the talents of a diverse workforce. We embrace an environment where employees enjoy a balance between their careers, families, communities, and personal...
-
Sales Development Representative Ii
hace 7 meses
Desde casa, Colombia Thermo Fisher Scientific A tiempo completo**Location/Specific Division**: Cali, Colombia. **How will you impact your position (Objective)**: Develop and implement the strategies given by the management, for the growth of the assigned area, promoting, negotiating, and acting as a factor of change in the different customers through TMF's solutions. Driving the sales of solutions that are in line...
-
Sr Director, Project Management
hace 7 meses
Desde casa, Colombia Thermo Fisher Scientific A tiempo completoAt PPD, a Division of Thermo Fisher Scientific, our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our...
-
Field Auditor Wfg
hace 7 meses
Desde casa, Colombia Transamerica A tiempo completoJob Family Regulatory Compliance - About Us At Transamerica, hard work, innovative thinking, and personal accountability are qualities we honor and reward. We understand the potential unleashed by leveraging the talents of a diverse workforce. We embrace an environment where employees enjoy a balance between their careers, families, communities, and...
-
Compensation Manager
hace 7 días
Desde casa, Colombia ArdentMills A tiempo completoThe ability to deliver results in first-time situations by inspiring others and working to earn trust every day. - The willingness to serve others with understanding, respect, and care. - The ability to operate with simplicity, clarity and transparency. - The willingness to effectively deal with and drive change. - The ability to organize, prioritize and own...
-
Senior Director of Equity
hace 6 días
Desde casa, Colombia TaskUS A tiempo completoWant to be part of a company that is changing the game for some of the world's most notable brands and disruptive companies? We thought so. TaskUs is seeking a Senior Director of Equity and Compensation who will work closely with the DVP of DVP Corporate Strategy on the design, implementation, and administration of executive rewards and equity programs. In...