Regulatory Affairs Specialist

hace 3 días

Bogotá, Colombia IQVIA A tiempo completo

Bogotá, 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 projects.

**Essential Functions**
- Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
- Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
- Understands the Scope of Work, deliverables for any given project;
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
- May prepare and deliver trainings, as appropriate;
- Performs other tasks or assignments, as delegated by Regulatory management;
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;

**Qualifications**
- Bachelor's Degree in Lifescience or related discipline.
- At least 2 years of regulatory affairs (postmarketing) experience: maintenance records, new records, regulatory activities.
- Fluent English: Spoken, Read and Written.
- It's a plus to have worked with other countries: USA, Canada.
- Good, solid interpersonal communication (oral and written) and organization skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Demonstrates self-motivation and enthusiasm;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

  • Regulatory Affairs Specialist

    hace 7 días

    Bogotá, Cundinamarca, Colombia Solventum A tiempo completo

    Job 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,...

  • Regulatory Affairs Specialist

    hace 1 semana

    Bogotá, Colombia Medtronic A tiempo completo

    At 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 |Food

    hace 4 días

    Bogotá, Colombia Symrise AG A tiempo completo

    Regulatory Affairs Specialist |Food & Beverage Regulatory Affairs Specialist |Food & Beverage Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Symrise AG Talent Acquisition LatAm|| HR Strategy ||Labour Relationship Management||Training & Development||Compliance||Internal Communication||Employer… About Us...

  • Regulatory Affairs Specialist

    hace 1 día

    Bogotá, Colombia Zimmer Biomet A tiempo completo

    At 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...

  • Regulatory Affairs Specialist

    hace 2 días

    Bogotá, Colombia Zimmer Biomet A tiempo completo

    At 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...

  • Manager, Regulatory Affairs

    hace 7 días

    Bogotá, Colombia Johnson & Johnson A tiempo completo

    **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...

  • Regulatory Affairs Sr. Specialist

    hace 7 días

    Bogotá, Colombia Bayer A tiempo completo

    **Regulatory Affairs Sr. Specialist** **YOUR TASKS AND RESPONSIBILITIES** - Given the complex regional regulatory environment, determines the regulatory strategy for achieving earliest approval with appropriate labeling, in line with the business objectives. - Accountability for lifecycle management for the specific Therapeutic Area portfolio of products...

  • Senior Specialist Regulatory Affairs Latam Andean

    hace 7 días

    Bogotá, Cundinamarca, Colombia International Flavors & Fragrances A tiempo completo

    Job Summary Senior Regulatory Affairs Specialist. Focused in Product Compliance and advocacy, business and customer support. Accountable to execute regulatory strategy in the Andean Region. Main focal point to the Functional Ingredients Business. Good relationship skills, good food regulatory knowledge (Andean). Participation in Trade Associations....

  • Regulatory Affairs Specialist

    hace 7 días

    Bogotá, Bogotá D.E., Colombia MSD LATAM A tiempo completo

    Job DescriptionRequisitosFormación Médico VeterinarioEducación Experiencia de 5 años en asuntos regulatoriosNivel de inglés intermedioFuncionesRespaldar al Director Científico en su actuación ante el Instituto Colombiano Agropecuario en Colombia, con el fin de asegurar el cumplimiento de las regulaciones regionales por parte de la operación de la...

  • Regulatory Affairs Specialist

    hace 3 días

    Bogotá, Cundinamarca, Colombia CooperVision A tiempo completo

    Carrying 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...