Regulatory Affairs Associate Consultant- PLM

ClinChoice; Colombia; Presencial; COP 30.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

ClinChoice is seeking a Regulatory Affairs Associate Consultant for a 12-month contract to support international regulatory submissions and client-facing activities. This role requires strong regulatory expertise, leadership, and the ability to work independently in a global CRO environment.

The position emphasizes high-quality deliverables, accountability, and collaboration across cross-functional teams in a dynamic client-focused setting.

Formación

• 3+ years regulatory experience.
• Demonstrated ability to support international product approval.
• Ability to work in a demanding environment with strong focus on quality and timelines.
• Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.

Responsabilidades

• Accountable for aligned markets regulatory in-scope ancillaries and samples.
• Understand aligned markets regulatory ancillary requirements.
• Manage aligned markets ancillary and samples requests to meet timelines for regulatory submissions.
• Work in a matrix environment with effective communication across multiple functions.
• Escalate to Client and Contractor contacts when timelines may not be reached.
• Maintain Clients systems and processes to reflect requests in real time.

Conocimientos

Regulatory experience

International product approvals

Leadership and teamwork

Advanced Microsoft Office

Strong communicator

Decisive and accountable

Learning quickly and applying new regs

Educación

Bachelor’s degree

Herramientas

Microsoft Office Suite

Descripción del empleo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Responsibilities

• Accountable for aligned markets for required regulatory in-scope ancillaries and samples
• Understand aligned markets regulatory ancillary requirements
• Manage aligned markets ancillary and samples requests are completed per agreed timelines in support of planned regulatory submissions
• Manage in a matrix environment with effective communication across multiple functions
• Escalate to Client and Contractor point of contact when timelines may not be reached.
• Maintain Clients systems and process throughout processing of request to ensure real time reflection of request is visible to all users.

Minimum requirements

• 3+ years Regulatory experience
• Demonstrated ability to support international product approval
• Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
• Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
• Can demonstrate leadership and team skills.
• Advanced Microsoft Office Suite skills.
• Highly efficient communicator.
• Acts decisively and seizes accountability
• Bachelor’s degree Level (desirable or equivalent work experience.
• Familiarity with pharmaceutical organizational Structures.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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