Regulatory Affairs Specialist

**The Opportunity**:Supports the Operations Senior Manager and the Regional Regulatory group, especially for the review and dispatch of the variation documentation and invoices management. Is the contact for distributors/regulatory agents of the assigned region. The position is responsible for registrations and the effective regulatory lifecycle management of CSL Behring's products in the distributor markets in the assigned region in close collaboration with the regulatory affairs managers of the distributors (customer) and at the manufacturing sites (internal).This is a hybrid role, which offers a combination of onsite and remote work.**The Role**:**Assigned Countries of regulatory responsibilities (all sites, all products)**:- Central America and the Caribbean.**Regulatory Coordination for the assigned countries**:Interface between distributors/regulatory agents (3rd parties), Global Regulatory Affairs and Commercial Operations Intercontinental for the assigned region:- Ensure that the distributors/regulatory agents follow CSL standards and guidelines to accomplish any regulatory activities. Is the primary contact for all distributors/agents and provide first line replies.- Responsible for optimal product compliance with approved regulatory status by supervising the regulatory activities.- Responsible to obtain marketing authorizations according registration plan.- Effective planning, coordination, tracking and communication of local requirements/regulations and submission deadlines to stakeholders.- Provide and maintain overview on pending and planned activities and manage prioritisation and new objectives.**Tender Operation Activities for the assigned countries**- Support tender submissions (bidding process, fulfilment) in close collaboration with Sales Managers and Supply Chain.- Responsible for tenders complete regulatory compliance control (from tender announcement through product dispatch to the distribution market).**Team support activities for GLAD**- Variation handling of all appropriate markets:- Uploading to SharePoint / distribution to countries as required.- Supervision of tracking / reporting as required.- Support of any upcoming project of the team (under supervision of the responsible team member).- Invoices management.- Coordinates and supports regulatory compliance in GLAD ( Group of Latin American Distributors ).**Strategy**- Ensure strategies are aligned within Commercial Operations and follow priorities as communicated by the supervisor.- Contribute to strategic CSL Behring projects as project manager or team member, as required.**Customer Relations**- Ensure appropriate, relevant and timely training of distributors/regulatory agents on adherence to all applicable CSL Behring policies/procedures and guidelines.- Ensure and organize, in collaboration with the supervisor that Registration Agreements and/or Confidential Agreements are in place with distributors/regulatory agents for the assigned region.- Facilitate mutual understanding and solution finding of country specific matters versus CSL Behring global interests.- Timely communication of upcoming audits and trainings.**Reporting & Communication**- Weekly oral management reporting of key issues (Jour Fix).- Consolidated written monthly report on key issues and progress.- Active participation in team meetings, trainings and workshops.**Your skills and experience**:- Minimum Bachelor's degree in life-sciences (pharmacy, chemistry, biochemistry).- Ability to negotiate fluently in English and Spanish.- Genuine interest to work in the industry.- Target and performance orientated, ability to work systematically, structured and under pressure.- Fast learner.- Strong interpersonal and communication skills.- A character of loyalty and integrity.- Good knowledge of MS-Office.**Our Benefits**:We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.**About CSL Behring**:CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.**We want CSL to reflect the world around us**:As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.**Do work that matters at CSL Behring**: