ASCENTOR Recruitment & Executive Search

Regulatory Manager | Pharmaceutical industry

1 day left

Location
Bucharest (RO)
Posted
24 Oct 2017
Closes
22 Nov 2017
Industry sector
Healthcare & Pharmaceutical
Contract Type
Permanent
Hours
Full Time
Travel
Up to 25%

On behalf of our client, a leading multinational company active in the Pharmaceutical industry, we are looking for a Regulatory Manager.

Job purpose:

  • Lead Medical Affairs both as the scientitifc expert in the related field and as a business partner;
  • Act as a Local Pharmacovigilance Responsible Person;
  • Act as a Person with responsibilties in Quality Assurance area for local Quality Management System;
  • Define regulatory affairs strategy and manage product regulatory activities by ensuring compliance and effective timelines within the territory;
  • Coordination of the regulatory activities between the Local Authorities and Global Regulatory Affairs;
  • Ensuring local compliance with applicable Pharmacovigilance regulations and the Group corporate policies;
  • Coordination and support of market access activities - pricing, reimbursement;
  • Support business continuity by interacting with internal & external stakeholders.

Responsibilities:

  • Lead Medical Affairs activities in Romania;
  • Participate in management team of Romania as member of the Romanian  Management Team;
  • Build a local Key Opinion Leaders („KOL”) network;
  • Support commercial in all their promotional activities (eg:in the development and approval of promotional material, presentations etc.);
  • Approve all marketing material to be in line with the approved labeling as per the dossier/ companies policies / local laws;
  • Follow local scientific literature;
  • Guarantee compliance with Romanian law;
  • Intake and forwarding of Adverse Events (concerning medicinal products, cosmetics, biocides, nutritionals - as applicable) to Global Pharmacovigilance & Risk Management (“GPRM”) or partner (as applicable); documentation and tracking of Adverse Events; reconciliation activities and documentation;
  • Forward Adverse Events regarding surgical and vision care products (medical devices) to the Global Product Safety Surveillance group or Materiovigilance Group EMEA, as applicable;
  • Perform follow-up activities as applicable and document them;
  • Acting as local contact person or local Qualified Person for Pharmacovigilance for local health authorities as required; 24/7 availability for EU QPPV and health authorities if required;
  • Submission of aggregate reports to local health authorities; documentation hereof if applicable;
  • Support of compilation of aggregate reports by providing requested data;
  • Support labelling update activities;
  • Support Direct Healthcare Professional Communication, additional risk minimization measures and other risk minimization measure activities according to Risk Management Procedures (in cooperation with Risk Management Group and partner, if applicable);
  • Perform/organize local literature search (journals not listed in EMBASE); documentation of local literature search;
  • Organize trainings for local affiliate employees incl. sales representatives as applicable;
  • Check for changes in local and European regulatory environment and inform upper the Group, in case of relevant new safety information;
  • Ensure update of pharmacovigilance related local SOPs on a regular basis or if required;
  • Act as local contact point for audits and inspections and related processes and inform the Group;
  • Ensure all company staff is trained and up to date on reporting of Adverse Events /Incidents;
  • Key contact with the Romanian Authorities regarding all Regulatory activities;
  • Develop, lead and drive regulatory strategies for new submissions & product lifecycle of Pharma products;
  • Ensure the maintenance and update of registrations in accordance with relevant legislation, regulations and guidelines and in accordance with Company requirements in conjunction with Global Regulatory Affairs;
  • Policy follow-up and influencing through local industry associations and regulatory forums;
  • Initiate and approve, as needed, all packaging material to be in line with approved labeling and applicable local regulations in the Group systems;
  • Address regulatory and technical queries from colleagues, health care professionals or the public;
  • Liaise and coordinate actions between Global Regulatory Affairs and local authorities;
  • Foster networking with the competent authorities to ensure company involvement in the regulatory changes and the prompt;
  • Manage the official pricing process with support of all Company function;
  • Support reimbursement negotiations activities (after commercial approval) towards the local body in coordination with Company appropriate function support.

Requirements:

  • Experienced regulatory professional in pharmaceutical industry with minimum 3-5 years relevant experience;
  • Ability to interpret and apply European and local regulatory policies and requirements for assigned portfolio;
  • Sound understanding and functional knowledge of the pharmaceutical industry with a clear understanding of the industry development;
  • Competent working knowledge of computer based systems such as Microsoft Office and controlled documentation systems;
  • Clear track record of effective teamwork, collaboration communication, and also demonstrated leadership ability in a cross-functional matrix team environment;
  • Product management along with planning and organizing by prioritizing and planning work activities and change agility;
  • Fluency in English.

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