Regulatory Affairs Sr. Specialist

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 https://www.bayer.com/en/strategy/strategy

YOUR TASKS AND RESPONSIBILITIES

• Ensure timely submission of the NDA applications in each PACA country according to the timelines in close coordination with operational specialist, local consultants and the country AR business partner to be able to contribute with the business objectives.
• Given the complex regional regulatory environment, determines the regulatory strategy for achieving earliest approval with appropriate labeling, in line with the business objectives.
• Accountability for lifecycle management for the specific Therapeutic Area portfolio of products related to: Regulatory Compliance of specific portfolio enabling PACA business continuity, mitigating risk and ensuring 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 Lead and Supports operational excellence opportunities & projects Database update and maintenance.
• Ensures transparent, timely and efficient communication with PACA Head, Business Partner, Therapeutic areas and the business Support Colombia RA operation to ensure planning compliance, execution, control and risk managements to guarantee the RA operation supporting all PACA process assigned Support RA operation/strategy for Colombia.

WHO YOU ARE

• Pharmacist or equivalent MBA degree is desirable.
• Experience: Minimum of 3 years of proven experience managing submission of innovative products (NDA) in Colombia Minimum of 5 years of proven experience supporting Colombia Operation Nice or have at least 1 year supporting RA CAC countries and managing lifecycle processes for Pharmaceutical products Specific knowledge or Further Education.
• Knowledge and understanding of the regulatory environment, procedures, policies and guidelines of Colombia, OMS,OPS and ICH Knowledge and understanding of international regulations for Pharmaceutical products ( EMA, FDA, ICH, PAHO-OMS GUIDELINES).
• Nice to have knowlegde in either Central America & Caribbean and Andean region RA legislation Knowledge and understanding of international regulations for Pharmaceutical products ( EMA, FDA, ICH, PAHO-OMS GUIDELINES).
• Proven analytical skills and abstract thinking.
• Ability to manage ambiguity and complexity; multiple projects at one time with competing priorities.
• Proven negotiation and influencing skills Business acumen and ability to generate insights, customer focused.
• Ability to communicate effectively both oral and written, demonstrated cross-functional communication skills.
• Ability to focus on multiple issues at one time, ability to organize, prioritize and manage regulatory activities in a changing environment often under time pressure.
• Ability to develop current strategies for diverse lifecycle topics.
• Ability to develop effective Regulatory solutions to diverse and complex business problems.
• Ability and flexibility to operate at times in crisis environment.

WHAT WE OFFER YOU

• Full time employment contact.
• Wide range of development opportunities.
• Competitive salary.
• Attractive benefits package.
• Good working conditions and comfortable working environment.
• Hybrid working type.

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.

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.