Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women''s Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world''s leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear. Business Planning & Administration We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.
If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes. The Director Regulatory Affairs & GTRA-Latin America acts as the Head of the Regulatory Affairs and Technical Regulatory Affairs organizations in the region and manage the group of country Managers.
.Oversees the development and implementation of all the regulatory strategies for new and existing products and implements the global strategies impacting the region.
.Ensures application of established policies and best practice regulatory standards within Latin America Regulatory groups for all filings, maintenance of existing product registrations and agency interactions.
Guides, directs, and leads the Global Technical Regulatory (CMC) organization in the development of strategic plans and assists with regulatory submissions for approval of new products and post approval
changes for marketed products. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency
.Assures that the Latin America regulatory strategies for the initiatives under responsibility are effectively implemented and maintained in line with changing regulatory and business needs.
.Develops and implements internal standards and policies in line with Latin America regulations.
.Effectively interfaces with teams and senior leadership personnel at global and regional level.
.Assesses regulatory issues and strategies for potential regulatory/business implications inside and outside of Latin America for all the therapeutic areas.
.Works to coordinate global management of high profile/high criticality regulatory issues, including those impacting promotional communication strategies.
.Develops and manages the regulatory and CMC processes within Latin America region and serves as experience resource within the region and across BCC R&D.
.Effectively plans and prioritizes resources and follows up to assure success.
.Drives the execution of the regional submission plan with the country RA teams in the region for new registrations and maintenance, during the life cycle of the product.
.Guides, mentors and motivates others within Latin America Regulatory and International Regulatory Affairs.
.Leads and leverages regulatory experience in internal and external interactions to provide direction and strategic input.
.Strongly supports BCC organization and works effectively within to achieve success.
.Communicates IRA vision and company LIFE values.
.Demonstrates influence across the BCC groups and R&D.
.Collaborates as a trusted and respected peer with the heads of R&D, Manufacturing and Quality to establish appropriate risk-based solutions which account for regulatory requirements. Works to integrate regulatory CMC requirements and expectations throughout the organization.
.Plays a leadership role with the regulatory authorities for major meetings, including planning and chairing of meetings.
.Oversees development and negotiation of overall plans regarding to assure viability for global or regional registrations. Align regulatory strategy to overall regulatory business strategy across all functional areas.
The Director Regulatory Affairs & GTRA- Region Latin America Adds value by ensuring that regional BCC commercial objectives are met by obtaining and maintaining product registrations and ensuring the
production of Module 3 dossiers for the products. Provides strategic regulatory input to ensure that the manufacturing, supply chain and commercial activities are in line with appropriate local regulatory
standards. This alignment of commercial, manufacturing and regulatory activities optimizes costs and timelines, resulting in faster time to market and realization of BCC commercial objectives.
Director Regulatory Affairs & GTRA- Region Latin America is responsible for deciding:
.Developing the regulatory strategy for the BCC products in the region (in alignment with commercial operations)
.Assigning resources to support the technical and regulatory activities for regional products.
.Deciding whether or not regional regulatory issues or trends impact the commercial objectives of the BCC business.
.Deciding the information to be provided to local affiliates for the registration and maintenance of regional products.
.A degree in the Life Sciences
.A post-graduate degree in business administration preferred
.Significant experience conducting regulatory-related business in the region
.Significant experience in the production of CMC documentation (Module 3)
.2 to 5 years of experience in a comparable position
.15+ years of experience in regulatory role
.5 years of Management experience with multi-cultural teams.
.Ability to establish strong relationships across different functions and cultures
.Proficiency in MS Office: Word, Excel and PowerPoint.
.Proficiency in MS Office: Project preferred
.Ability to communicate effectively in English both verbally and in writing.
.Strong communication and negotiation skills.
.Fluency in spoken and written language(s) appropriate to the region is highly preferred.
.Willingness to travel (up to 40%).