Regulatory Affairs Manager- Pharmaceuticals

We are seeking a meticulous and experienced Regulatory Affairs Specialist to manage and execute the registration, licensing, and lifecycle maintenance of pharmaceutical products (including Finished dosage forms, Biologics and Medical device) in the Colombian market. The ideal candidate will have in-depth knowledge of INVIMA regulations, a proven track record of successful drug registrations, and the ability to navigate the complex regulatory landscape to ensure timely market approvals. Have the ability to compile documents for Biological preparations, Chemical drug preparations, APIs, cosmetics, medical devices, etc., as well as translation and submission capabilities. Also possess the ability to hold regular meetings with INVIMA.

Key Responsibilities:

1.Registration Strategy & Submission:

• Lead end-to-end registration processes for new pharmaceutical products, line extensions, and variations in compliance with INVIMA requirements.
• Prepare, compile, and submit high-quality registration dossiers (CTD format), ensuring accuracy and completeness of all modules.
• Develop and execute regulatory strategies for optimal approval pathways and timelines.

2.Regulatory Compliance & Maintenance:

• Maintain existing product licenses, including renewal applications, change notifications, and annual updates as per INVIMA regulations.
• Monitor and implement changes in local regulations, guidelines, and technical requirements, assessing their impact on company products.
• Ensure all regulatory activities adhere to local laws, company SOPs, and quality standards.

3.Authority Interaction & Liaison:

• Act as the primary point of contact with INVIMA and other relevant health authorities for registration-related matters.
• Manage queries, objections, and communications from health authorities, coordinating timely and appropriate responses.
• Facilitate meetings and interactions with regulators as needed.

4.Cross-functional Collaboration:

• Work closely with R&D, Quality Assurance, Pharmacovigilance, Supply Chain, and Commercial teams to align regulatory requirements with business objectives.
• Provide regulatory input for product development, labeling, packaging, and promotional materials.
• Support regulatory aspects of product launches and market access activities.

5.Documentation & Intelligence:

• Establish and maintain up-to-date regulatory databases, archives, and tracking systems for applications, approvals, and certificates.
• Prepare regulatory reports and summaries for internal stakeholders.
• Conduct regulatory intelligence gathering and benchmarking.

Qualifications:

1.Education:

• Bachelor's degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related life science field.

2.Experience:

• Minimum 8 years of hands-on pharmaceutical regulatory affairs experience in Colombia, with a demonstrated history of successful product registrations with INVIMA.
• Experience with Generics, Biologics and Medical device registration is highly preferred.

3.Skills & Competencies:

• Expert knowledge of Colombian pharmaceutical regulations, INVIMA processes, CTD dossier requirements, and regional regulatory trends.
• Strong project management skills, with attention to detail and ability to manage multiple deadlines.
• Excellent written and verbal communication skills for effective interaction with authorities and internal teams.
• Proactive, analytical, and solution-oriented mindset.
• Proficiency in regulatory software and Microsoft Office Suite.

4.Language Requirements:

• Native or fluent Spanish; professional working proficiency in English (reading/writing technical documents is essential).

5.Other Requirements:

• Colombian national or holder of valid work authorization for Colombia.
• Willingness to travel occasionally within Colombia or internationally for training or meetings.