Senior Associate, Regulatory Affairs

Senior Associate, Regulatory Affairs


Solna, Sweden

Job Description

We are looking for a Senior Associate, Regulatory Affairs to support the activities of the Nordic affiliate’s (Denmark, Finland, Iceland, Norway, Sweden) Regulatory Affairs team to interact with local Nordic Regulatory Authorities and other stakeholders to ensure that the company complies with Nordic countries 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

Reports to: Senior Manager Regulatory Affairs, Nordics

Essential Duties and Responsibilities

Core Technical Regulatory Contribution

  • Interaction with Local Health Authorities (HA);
  • Support the interaction and communication with the local HAs;
  • Works proactively to build and maintain contacts with relevant local HA personnel at own level;
  • Support interactions with other departments/functions for response to local HAs;
  • Support for incidents involving regulatory matters (as required);
  • Support the management of relevant local HA inspections;
  • Prepare regulatory (submission) documentation with direct supervision from more senior associates regarding;
  • Quality defects/falsified or counterfeit products/batch recall management;
  • Out of stock situation management;
  • Dear Healthcare Provider Communications submissions and follow-up until approval;
  • Risk Minimization Measures submissions and follow-up until approval.

Regulatory Submissions

  • Prepares regulatory submission documentation with direct supervision from more senior regulatory personnel in order that all regulatory submissions to local HAs are done in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects;
  • Main types of submissions are (not-exhaustive):
    • Clinical trials applications, amendments and other clinical trials submissions;
    • Compassionate Use & Early Access applications;
    • Marketing Authorisation (MA) applications;
    • Variations and other MA maintenance applications;
    • Import permits;
    • Risk Minimization Activities materials;
    • Dear Health Care Professional communication;
    • Promotional materials.

Local Statutory Responsibilities and Liabilities

  • Support the activities to 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;
  • Act as a delegate for certain responsibilities carried by the local Gilead representative;
  • Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead;
  • Support to ensure compliance with local law and regulation and consistency with global procedural documents;
  • Contribute as requested to the creation, maintenance, training, evaluation and tracking of all 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;
  • Support the activities needed to manage Regulatory Compliance audit within the affiliate;
  • Support the activities needed to maintain GDP license in the country, as required and set up internal and 3PL audits management as appropriate;
  • Support the activities needed to ensure the establishment of Quality Agreement where required with 3PL;
  • Prepares regulatory submission documentation to HA for promotional material for assigned product(s) with direct supervision from more senior regulatory personnel, if applicable;
  • Support the activities needed to ensure compliant labeling for Gilead medicinal products in the country (SmPC, PIL, packaging) and manage timely updates for assigned product(s).

Regulatory Intelligence

  • Knowledge of the main sources of Regulatory intelligence and the Affiliate role in rapidly screening and communicating changes to regulatory information to International Regulatory, Regulatory Intelligence and the local Affiliate;
  • Monitor competitor regulatory information such as approvals, changes in label and other relevant local details.

Professional Experience/Key Skills

  • Typically requires a degree in a scientific field and/or master in regulatory affairs and min of relevant experience in regulatory affairs;
  • Experience in and understanding of role of RA and regulatory requirements in Pharmaceutical/Biotech Industry including ICH requirements and regional requirements and understand current trends in the local territory is preferred;
  • Excellent organization skills and ability to work on several projects with tight timelines is required;
  • Excellent verbal and written communication skills and interpersonal skills are required.

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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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