REGULATORY AFFAIRS SPECIALIST - ALBANIA & KOSOVO

Rreth nesh

The HeadHunter Group is an innovative Staffing and Recruiting Company operating in Albania, Kosovo, Montenegro, Macedonia, Greece, Bosnia and Herzegovina and USA. We offer the newest mentality in Staffing industry and our core business are Candidates and Clients.

Titulli i postimit * REGULATORY AFFAIRS SPECIALIST - ALBANIA & KOSOVO
Kategoria Medical/Health/Social
Lloji i punës Full Time
Përshkrimi i Punës

For our Client, a well-known international company in the field of pharmaceuticals, we are looking for the following position in Albania & Kosovo: 

REGULATORY AFFAIRS SPECIALIST

JOB PURPOSE

Regulatory Affairs: To be responsible for the execution of all regulatory tasks with the purpose to ensure and manage rapid regulatory approvals and maintenance on the market, all with focus on supporting and driving the local business in line with global RA and Country Pharma Organization (CPO) plans. To provide regulatory expertise within the DRA department and across the CPO for fast market access.

ROLES AND RESPONSIBILITIES

  • Professionally understands the regulatory environment and processes;
  • Provides regulatory know-how and knowledge regarding EU and local regulations;
  • Understands portfolio and is aware of the business potential in the country;
  • Effectively recommends and implements regulatory strategy;
  • Builds and maintains excellent relationship with competent regulatory authorities;
  • Supports global regulatory functions for applications filed under the EU systems, namely Mutual Recognition and Centralised Procedures;
  • Provides support to other international projects as required;
  • Performs all submissions and approvals for medicinal products and clinical trials according to the timetable given by the Head Quarter (HQ) and according to the CPO plan. Maintains full responsibility of all regulatory activities on assigned projects and prioritizes activities to ensure completion of goals. Works to minimize regulatory issues and helps prevent unnecessary delays;
  • Supports the registration activities related to product launches;
  • Supports regulatory support key to meeting launch plans and maximising product claims as well as advocacy activities as required;
  • Manages all regulatory translation activities as required;
  • Ensures smooth production transfers and variations resulting in business continuity;
  • Manages the discontinuation of pProduct lLicenses for allocated products that are to be pruned;
  • Provides Basic Succinct Statements (BSS) to be used in promotional materials/Risk Management Plan (RMP) educational materials as required;
  • Supports local RA Head in monitoring the whole regulatory approval process identifying critical steps and suggesting optimization actions;
  • Responds to technical and scientific HA questions. Coordinates, timely submissions and follows-up response documents to HA requests;
  • Timely submits PSURs, DSURs and RMPs as necessary;
  • Maintains all RA related databases and information systems in line with internal policies, KPIs and SOPs;
  • Accurately maintains records and archives;
  • Participates in the processes for the preparation of packaging materials and implementation of all artwork changes in line with internal policies and SOPs and informs the responsible headquarter department when changes need to be implemented as per Key Performance Indicators (KPIs);
  • Monitors regulatory environment and provides timely regulatory competitive intelligence including generics;
  • Provides regulatory input to reimbursement applications;
  • Participates in cross functional teams concerning products under responsibility;
  • Assists in the review of promotional and educational materials for compliance with legislation and internal rules (NP4) (regulatory aspects) as required. Coaches new RA associates in regulatory aspects and internal procedures;
  • Complies at all times with all KPIs Key Performance Indicators as set by HQ Headquarters and the Albania & Kosovo RA Department;
  • Attends all training locally and abroad as required. Timely completion of all mandatory training;
  • In case of receiving a product complaint, reports within set timeframes to the Quality Assurance Responsible Person (QARP);
  • In case of receiving an Adverse Event Report, reports within set timeframes over to the CPO responsible person;
  • Faithfully adhere to and strictly observe the company Code of Conduct, the Corporate Citizenship Guidelines, company Pharma Principles and Practices for Professionals (NP4) and any other guidelines and/or regulations issued by company or local legislation, including reporting of adverse events and technical complaints;
  • Gain and maintain competitive product licences and ensure regulatory compliance;
  • Facilitate rapid approval of new products, indications and dosage strengths for the local market;
  • Maintenance of existing Product Licences (renewals, variations and documentation updates) to comply with the highest ethical standards in the industry and all KPIs;
  • Attend and contribute to meetings and update/ train relevant office personnel as required;
  • Assist in the review of promotional material for consistency with the licence as required and with NP4;
  • Working closely with global and local colleagues from RA and relevant other line functions to advise and agree on regulatory strategy, clinical development plans and deliverables. Participation in regional RA sub-teams;
  • Critically evaluates data and argumentations in order to contribute to high quality submissions and to eliminate deficiencies prior to construction and submission of Marketing AAuthorisations (MAs) applications within agreed timeframes;
  • Critically evaluates data and argumentations in order to contribute to high quality submissions and to eliminate deficiencies prior to construction and submission of CTA applications to Health Authorities within agreed timeframes;
  • Where applicable organises and participates in Health Authority scientific advice and pre-submission meetings, and other clarification meetings with global teams to support product development programs;
  • Creates and maintains the country specific part of dossier;
  • Coordinate the internal process of approval of SmPC, PIL and labelling, especially for products that have obtained marketing authorisation via the centralised, MRP or DCP procedures. Prepare SmPC, PIL and labelling according to the local guidelines for products registered in the national procedures;
  • Monitors and ensures an efficient assessment process to expedite and optimise the outcome of the submissions. When appropriate, conducts negotiations with Health Authority to ensure best possible product labelling and timely delivery of the commitments to the Health Authority within deadlines;
  • Manages regulatory aspects of compassionate supplies;
  • Proactively monitors status of local post-approval commitments made to Health Authority and ensures their timely completion;
  • Works closely and swiftly with cross functional teams in case of critical issues, e.g. related to product recall or other quality related issues;
  • Proactively builds internal relationships (e.g. Business Franchise/ BU, ICRO, Market Access, Marketing, TechOps, DS&E, Global colleagues), so that business needs are met;
  • Provides regulatory advice and support for divestment and in-licensing opportunities;
  • Upon request provides regulatory advice to internal global and local business partners on all aspects of development and maintenance work including advice on data requirements, strategy, medicines legislation/ guidelines, to ensure informed decision making and best chance of optimal assessment timing and outcome;
  • Monitors changes and future trends related to regulatory issues which are likely to affect company interest and communicate to local management, local RA group and HQ as appropriate;
  • Maintains close interaction with the QA on all quality related matters;
  • Supports the QA in ensuring that all drug products are released in accordance with the registered specifications and are released to the market in accordance with local/international regulations;
  • Support in updating and maintaining local SOPs and other requirements of the Quality System.

 

KEY PERFORMANCE INDICATORS:

  • Timely delivery of regulatory approvals for CPO. Adherence to KPIs defined by HQ;
  • Timely submission of regulatory applications. Quality of the submissions;
  • Meeting important deadlines agreed for the submission and approval of regulatory applications. Quality of interaction with external and internal customers;
  • Compliance of regulatory information in RA related databases;
  • No stock-out due to inefficient RA procedures;
  • Performance review;
  • Compliance with regulations and internal procedures (NP4, SOPs, etc);
  • Dossier content quality? No Health Authority requests triggered by missing (known) deliverables or non-addressed potential issues;
  • Interaction with the assessors of the Medicines Authority to promote the assessment of these applications as quickly as possible through;
  • Knowledge in European pharmaceutical regulations, directives, and guidelines and the local regulatory environment;
  • Relationships with key assessors from the Medicines Authority;
  • Develop relationships with regulatory colleagues in Global DRA.

Detyrat Kryesore

DESIRED PROFILE:

EDUCATION/EXPERIENCE

  • University Degree, Health Care Sciences Professional (e.g. Medical Doctor, Pharmacist);
  • 5 years pharmaceutical or clinical research experience;
  • Clear and full understanding of relevant pharmaceutical regulation and approval processes;
  • Strong understanding of regulatory environment in the country;
  • Business sense;
  • Strong organizational, communication, negotiation and interpersonal skills;
  • Sense of effective organization (helicopter view) and initiative (proactive & autonomous sense);
  • Knowledge of national and international regulations for pharmaceuticals;
  • Knowledge of pharmacological and medical terminology;
  • Excellent communications, interpersonal and negotiation skills;
  • Quality and focus oriented;
  • Computer skills;
  • 3-4 years Regulatory Experience;
  • English – fluent, spoken and written.

Tjetër (Opsionale)

NOTE: This job description is not intended to be all-inclusive. The employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Are you interested in a new challenge in an innovative company? Have you answered well our questions related this position? Then we look forward to getting to know you and offer to you a very innovative challenge that will change your life forever! The interested candidates are invited to send their application documents (a Cover Letter and a CV in English) at: [email protected] if you have any technical questions related the application, please, contact directly Mrs. Ergesta STERMASI on mobile no. +355 682033430 (Monday - Friday) until 15/ 10 / 2017.

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