Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Gilead

Prague, Czech Republic

Job Description

Serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country applicable legislations and regulations pertaining to our portfolio (at all stages of the product’s life cycle) i.e. ensure that Gilead medicinal products can be developed, authorized, maintained on the market.

Key RA Responsibilities

  • Serves as a core member of the country brand/launch team or international working group as the representative of regulatory affiliate;
  • Represent RA within cross-functional and/or cross-regional regulatory sub-teams;
  • Plan, monitor, allocate and optimize management of activities with regards to portfolio evolution as well as regulatory changes;
  • Support the Regulatory Head on National Scientific Advice and pre-submission meeting preparation and follow-up;
  • Co-ordinates submissions and responses to local HAs involving input from other departments/functions;
  • Ensure that Gilead fulfills all requirements linked to the Marketing Authorization/ local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder;
  • Ensure compliant labeling for Gilead medicinal products (SmPC, PIL, packaging) and manage timely updates for assigned product;
  • Ensure promotional material review and approval for assigned product;
  • Contribute in the monitoring and report of external relevant changes and competitor regulatory information to concerned stakeholders within the company at local and global level.

Key GDP Responsibilities

  • Acts as subject matter expert and/or assists with the management of local HA inspections (as required);
  • Lead or assist the Regulatory Head in leading the creation, maintenance, training, evaluation and tracking of local regulatory owned procedural documents; including policies, SOPs, manuals and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in the scope of GMP/GDP, GPvP and GCP for assigned product(s) or projects;
  • Management/support of quality defects/falsified or counterfeit products/batch recall management;
  • Management/support of product out of stock situations;
  • Maintain GDP license in the country, as required and have the capability to set up internal and 3PL audits as appropriate if required by Reg Head.

Professional Experience/Key Skills

  • Typically requires a PhD or Masters in Pharmaceutical Sciences or equivalent discipline and minimum 5 to 8 years of relevant experience in regulatory affairs and GDP;
  • Previous role as Czech GDP Responsible Person;
  • Strong experience in understanding the role of RA and regulatory requirements in Pharmaceutical/Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate;
  • Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities;
  • Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate;
  • Previous people management experience is beneficial and experience working with Regulatory Authorities essential;
  • Good decision making skills are important;
  • Excellent verbal, written, organization skills and interpersonal communication skills required;
  • Excellent verbal and written English.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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