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Regional Regulatory Affairs Coordination Manager, South America


Location:
Greater Buenos Aires, Argentina
Language(s):
Only English Required
Job Ref:
589303892
Company:
CSL Behring
Job Description
Our CSL Behring office in Buenos Aires, Argentina is currently looking for a& Regional Regulatory Affairs Coordination Manager. This role& is responsible for registrations, effective regulatory lifecycle management of CSL Behring’s products in the distributor markets in the assigned countries in close collaboration with the regulatory affairs managers of the distributors (customer) and at the manufacturing sites (internal).&


The& Assigned countries of regulatory responsibilities: Bolivia, Colombia, Ecuador, Paraguay, Peru, Uruguay and Venezuela

&

What you’ll do:

&

1. Regulatory Activities:

  • Negotiating challenging but achievable registration projects for area of responsibility in collaboration with the supervisor, the responsible Area Manager and Global Regulatory Affairs as well as the distributor’s regulatory functions.
  • Prepare applications, variations, labeling changes and renewals documents for all CSL products with Global Regulatory Affairs.
  • Plan, coordinate, track and communicate effectively local requirements and submission deadlines.
  • Provide and maintain overview over pending and planned activities and manage prioritization.
  • Ensure full compliance of CSL Behring products with local Regulatory regulation.
  • Ensure for each distributors or Agent that:& & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & the regulatory contract is in place as required& & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & check and first level approval of service invoices from distributors or Agent for& & & & & & & & & & & & regulatory services
  • Provide an appropriate training to the distributors relating to regulatory activities.

2. Packaging Material and Printing Instruction

  • Coordination and approval of CSL Behring product packaging materials.
  • Ensure that country specific labeling requirements for private and tender markets are fulfilled locally through correct Printing Instructions.

3. Safety & Quality support Safety

  • Support the RSO (Regional Safety Officer) in safety reporting in the assigned region
  • Support the reporting of Adverse Drug Reaction within assigned region.
  • Ensure seamless flow of critical information from and to local regulatory agents, distributor and RSO.

4. Quality

  • Support RQO (Regional Quality Officer) in quality activities in the assigned region

5. Tender Operation Activities

  • Preparation of tender submissions (bidding process, fulfilment) in close collaboration with Area Managers, Supply Chain and Logistics.
  • Analyse tender requirements, timelines and specifications
  • Post-submission follow up (e.g. appeal statement)

6. Customer Relations

  • Support the selection of qualified Regulatory staff at the distributor/agent.
  • Ensure appropriate, relevant and timely training of Regulatory agents on adherence to all applicable CSL Behring policies/ procedures and guidelines.
  • Ensure and organize that the appropriately reviewed and signed Registration Agreements and Confidential Agreements are in place with each collaboration party (distributor, regulatory agent).
  • Facilitate mutual understanding and solution finding of country specific matters versus CSL Behring global interests.
  • Timely communication of upcoming inspections and internal coordination with the audit group.

7. Organization

  • Adherence to relevant CSL Behring policies, guidelines and SOPs.
  • Ensure that CSL Behring SOPs and policies are known and adhered to within the Distributor Business organization. Contribute to strategic CSL Behring projects as project manager or team member, as required.

8. Strategy

  • Contribute to strategic CSL Behring projects as project manager or team member, as required.

9. Reporting & Communication

  • Weekly oral reporting of key issues (Jour Fix) to supervisor.
  • Written monthly report on key issues and progress in Regulatory matters throughout the area of Responsibility.
  • Regular distributors and regulatory team meetings. Active participation in team meetings, trainings and workshops.
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Skills you’ll need:

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Education:& Masters, bachelors or equivalent degree in life-sciences (Pharmacy, Biology, Medicine or Chemistry).

Experience: A minimum of 4 years of professional experience in regulatory affairs& in Centro America & Caribbean or South America in a multinational innovative pharmaceutical company.


Languages: Fluent in English and Spanish.

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