Regulatory Affairs Manager

AmerisourceBergen; Colombia; Presencial; COP 167.516.000 - 241.969.000; Jornada completa

Descripción de la vacante

A global healthcare service provider in Colombia is seeking a Regulatory Affairs professional to manage lifecycle activities for pharmaceutical products. You will ensure regulatory compliance, manage project timelines, and support submissions and changes while working collaboratively with local health authorities. Ideal candidates will have a Bachelor's or Master's degree in Pharmacy or a related field, and at least 5 years of experience in regulatory affairs. This is a full-time position offering competitive benefits.

Formación

• Minimum of 5 years’ experience in regulatory affairs in the pharmaceutical or healthcare industry or consulting.
• Excellent project management and stakeholder engagement skills.
• Ability to work independently in a fast-paced environment.

Responsabilidades

• Conduct regulatory affairs activities for lifecycle management of pharmaceutical products.
• Support change applications and dossier compilation.
• Ensure compliance of product information and marketing authorization processes.
• Maintain databases and manage local regulatory requirements.

Conocimientos

Project management

Stakeholder engagement

Independent work

Ability to manage multiple projects

Educación

Bachelor’s or Master’s degree in Pharmacy, Life Sciences or related field

Descripción del empleo

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Responsibilities

• Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to:
• Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety) including submission strategy
• Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
• Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
• Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team
• Update/local Product Information (Labelling translation)
• Check regulatory compliance of product information/artworks
• Marketing Authorization withdrawal
• Marketing Authorization Holder transfer
• Licence renewal
• Periodic Safety Update Report contribution
• Invoice check (e.g. Authority invoices)
• Request Translation/additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices
• Databases maintenance: archiving, tracking
• Management of local Regulatory Affairs requirements (local regulatory intelligence)
• National Competent Authorities electronic systems for submission as locally required
• Contact with the local Health Authority on behalf of the client
• Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities
• Support of Country Regulatory Affairs Head in issue management (e.g. Product Quality Controls Standards Quality, Safety issues like stock out situations management, Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees)
• Review of Promotional Materials

Education

• You have a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field

Experience

• Minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting
• Excellent project management and stakeholder engagement skills
• Ability to work independently and in a fast-paced consulting environment
• You thrive on diversity and challenge and can effectively project manage and deliver several projects at once

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies: PharmaLex Australia

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request‑by‑request basis. Messages and emails regarding anything other than accommodations requests will not be returned