Regulatory Affairs Specialist Ph Paca
hace 1 semana
**Regulatory Affairs Specialist PH PACA**
**TASKS AND RESPONSIBILITIES**
- Accountable for the regulatory lifecycle management of products or assigned processes.
- Responsible for Regulatory compliance of specific portfolio of products or assigned processes enabling business continuity. Ensure that marketed drugs are in conformance with local government guidelines and regulations.
- Develop and implement regulatory strategies to support lifecycle activities (ie. submissions, renewals variations, deviations and amendments).
- Prepares dossiers for submissions and amendments.
- Ensures KPIs are achieved.
- Supports and may lead operational excellence opportunities & projects.
- Database update and maintenance.
- Revision & Approval of Artworks.
- Preparation, printing and submission of CMC, Labeling changes, advertisement, stock depletion to the Health Authority.
- Define strategy, management and implementation of CMC, Labeling changes including major, minor submission to Health Authorities.
- Compilate and negotiate with other stakeholders the needed activities to get timely dossiers, documents, samples to perform submissions, approvals and to guarantee RA ontime delivery to supplr supply or launches processes.
- Lead process to request of samples, analytical standards, legal documents (CPPs, GMPs, legal declarations, statements, power of attorney etc) using Bayer Global tools in accordance to specific requirements and timelines of each country/process.
- Request of legal translations and legalization internal and to external consultants.
- Maintain timely updated assigned data bases.
- Follow up submissions to ensure timely submission, approval and detect risk which could impact supply or compliance.
- Responsible of the physical and electronical archive.
- Support activities to make feasible the regulatory operation such as agreements, payments, purchase orders, reports and related activities.
**WHO YOU ARE**
- Pharmacist, or similar education with emphasis in medicines and medical devices.
- Minimum of 3 years Regulatory Affairs experience, with at least 2 year of proven regulatory lifecycle management for Pharmaceutical products including medical devices.
- Intermediate English level is required.
- Knowledge of multicountries RA submissions is desired.
- CMC and labeling changes experience is required.
- In-depth knowledge and understanding of the regulatory environment, procedures, policies in Colombia or PACA countries.
- Knowledge and understanding of international regulations for Pharmaceutical products ( EMA, FDA, ICH, PAHO-OMS GUIDELINES).
- Proven self-management and analytical skills.
- Proven Regulatory Affairs knowledge and capabilities to plan, execute and perform Follow up of major and miner submissions at the Health Authority for Medicines and Medical Devices.
- Proactivity and teamwork.
- Ability to manage ambiguity and complexity; multiple projects at one time with competing priorities.
- Proven negotiation and influencing skills with internal and external functions.
- Ability to communicate effectively both oral and written, demonstrated cross-functional communication skills.
- Ability to develop effective strategies for diverse lifecycle problems; ability and flexibility to operate at times in crisis environment.
**WHAT WE OFFER YOU**
- Hybrid Working Style.
- Full-time employment contract.
- Attractive benefits package.
At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people unique capabilities, self-experiences, and aspirations. We, intentionally seek diversity, to enable our people bring their fullest potential out and encourage others to likewise do so. Our company wins, when we leverage our capabilities to lead the cultural transformation in our business, positively impacting the society.
**Application Period**:
- 12/24/2024 - 01/21/2025
**Reference Code**:
- 834945
**Division**:
- Pharmaceuticals
**Location**:
- Colombia : Cundinamarca : Bogota
**Functional Area**:
- Regulatory Affairs
**Work Time**:
- Full Time
**Employment Type**:
- Regular
**Contact Us**
**Address**
**E-Mail**
- Bogotá, Colombia
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