Regulatory Affairs Analyst
Reporting to the Sr. Manager, Operations, Group of Latin American Distributors (GLAD), as the Regulatory Affairs Analyst, you will support the Regional Regulatory group with review of documentation for NDAs, renewals, dispatch of variations, and invoice management. You will be the contact for distributors/regulatory agents of the assigned region. You will be responsible for registrations and the effective regulatory lifecycle management of CSL Behring’s products in the distributor markets in the assigned region. You will work 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.
Assigned Countries of regulatory responsibilities (all sites, all products)
- Mixed group of countries in Central America, South America, and the Caribbean, COMISCA (Council of Ministers of Health of Central America), PAHO (Pan American Health Organization).
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 distributor/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.
- Responsible to maintain the marketing authorizations: prepare and support applications, variations license maintenance, labelling and renewals documents according to local requirements and in close collaboration with Global Regulatory Affairs.
- 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
- Review local dossier for NDA and renewal.
- Variation handling of all appropriate markets:
- Uploading to SharePoint / distribution to countries as required and any other platform required.
- Supervision of tracking / reporting as required.
- Support of any upcoming project of the team (under supervision of the responsible team member).
- Invoice management.
- Coordinates and supports regulatory compliance in GLAD.
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.
- Minimum Bachelor’s degree in life-sciences (pharmacy).
- 1 - 2 years of work experience strongly preferred.
- Excellent verbal and written communication and presentation skills in English language and Spanish.
- Target and performance oriented, ability to work systematically, structured and under pressure.
- Good planification and self-management.
- Strong interpersonal and communication skills.
- Able to work and communicate effectively and collaboratively across Affiliate functions, the GCSP organization and other global CSL functions.
- Ability to establish and maintain good working relationships with internal and external stakeholders.
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.
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.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
