Regulatory Affairs Specialist PH PACA Ever feel burnt out by bureaucracy?
Us too.
That's why we're changing the way we work— for higher productivity, faster innovation, and better results.
We call it Dynamic Shared Ownership (DSO).
Learn more about what DSO will mean for you in your new role here.
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.Compile and negotiate with other stakeholders the needed activities to get timely dossiers, documents, samples to perform submissions, approvals and to guarantee RA on-time delivery to supply or launches processes.Lead process to request 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 legal translations and legalization internal and to external consultants.Maintain timely updated assigned databases.Follow up submissions to ensure timely submission, approval and detect risk which could impact supply or compliance.Responsible for the physical and electronic 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 years of proven regulatory lifecycle management for Pharmaceutical products including medical devices.Intermediate English level is required.Knowledge of multicountry 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 minor 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 orally and in writing, 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.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's unique capabilities, self-experiences, and aspirations.
We intentionally seek diversity to enable our people to 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 society.
Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.
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