Regulatory Affairs Lead

**Regulatory Affairs Lead**

**WHAT YOU WILL DO**

The role exists to lead and coordinate Regulatory Excellence activities in Colombia, ensuring compliance to company Global Regulatory requirements (processes & tools) and to local Country Regulations in liaison with all the concerned areas. Responsible for acting in compliance with country policies and practices to reduce company´s exposure to regulatory risks. Assure Governance within Regulatory COL, in line with RA SAM and GEM/GRA definitions. Overview of Regulatory compliance. Responsible for providing Regulatory support to specific Projects as per Business needs.

This position is also accountable of supporting implementation of all regulatory related activities from the business strategic plan to obtain timely marketing authorization approvals of new products and line extensions and guarantee optimal Portfolio Lifecycle Maintenance activities implementation. Lead activities related to regulatory intelligence and monitoring.

**WHAT YOU WILL WORK ON**
- Provide internal customers with operational expertise and support.
- Enhance the operational performance and quality output through continuous process improvement.
- Coordination of relevant RA Dashboards and Monthly Reports Lead implementation of regulatory strategies and activities for new and existing licenses for Colombia.
- Identify, align and implement risk mitigation strategies for all regulatory processes.
- Perform regulatory intelligence strategy for Colombia by monitoring of regulatory status for competitors and monitoring, assessing impact and scaling up of new regulations.
- Lead change control process implementation for regulatory driven changes in Colombia interacting with quality assurance and supply chain teams in defining implementation strategies and follow-up. Support Regulatory affairs strategies implementation on governmental entities (lNVIMA) and industry associations.
- Participate actively and support new product launch projects, in accordance with regulatory compliance.
- Provide regulatory support to tender processes and any other business-related process in which regulatory assessment would be required.
- Ensure regulatory systems and databases are timely maintained.
- Maintain the local RA SOPs updated according with the new regulations.
- Keep on track regulatory submissions and define strategies to comply with expected approval dates.
- Provide Regulatory support on specific Area projects Interact with internal stakeholders / Solve interfaces problems
- Coordination of Trainings for Newcomers
- Foster collaboration with other functions Compliance of internal policies.
- Support on internal RA tools & systems Support on audits & follow up on CAPAs
- Support to tenders (RA/Technical requirements)
- Contribute to budgeting processes and ensure expenses compliance
- Maintain a high level of confidentiality with sensitive information

**WHO ARE WE LOOKING FOR**

**Experience & Education**:

- Education: Bachelor of Pharmacist. Post-graduation/MBA or any other business management related studies is desirable.
- 6-year work experience in Regulatory Affairs. 4 years of work experience as a team and/or project leader.
- High level knowledge of pharmaceutical industry
- Preferable knowledge in other related areas like finance, supply chain, marketing, medical affairs and market access.
- Solid knowledge of Colombia´s regulatory environment and Health Authority operations.
- English language skills: advanced
- Solid knowledge of drug products (Biologics and small molecules) and medical devices regulations in Colombia
- High level relationships with local HAs and trade associations.
- Regulatory strategies development.

**Competences & Skills**:

- Competencies based on proactivity, discipline, punctuality, responsibility
- Multidisciplinary team working experience
- Critical thought and problem resolution
- Teamwork and communication
- Focused on the customer
- Management problem solving skills
- Business acumen
- Effective communication skills to present effectively, both verbally and in writing, scientific and strategic concepts.
- Close relationships with the HA and trade associations High power of influence and negotiation with external stakeholders.

**LOCATION**:Bogotá, Colombia.

**Locations**:
Bogota, Colombia

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time