Head of Regulatory - Czech Republic & Slovakia

Place of work
Bratislava
Contract type
full-time
Start date
1.3.2019
Basic wage component (gross) and other rewards
From 3500€ - the seniority of candidate will be taken into account in the job offer + annual bonus based on the ability to meet the company's targets

Information about the position

Job description, responsibilities and duties

GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. For our activities we are looking for candidates for the position:

Head of Regulatory - Czech Republic & Slovakia
Job Purpose
• Leadership of Regulatory activities, strategy and compliance for pharma and vaccines product portfolios in Czech Republic & Slovakia
• The development and implementation of standardized, efficient and compliant processes across the 2 markets and support to the cluster head.
• Line management, coaching and development of a team or Regulatory staff across 2 markets
• Be an authority on the regulatory framework in Czech Republic & Slovakia (with support from local point of contact as required) and Europe to provide guidance to the local business to ensure compliance and support commercial growth
Key Responsibilities
• Lead regulatory strategy for Portfolio to underpin the Pharmaceutical business in Czech Republic and Slovakia to support competitive license approvals, market access, product launch and supply continuity.
• Leadership of regulatory affairs activities for product portfolio in Czech Republic and Slovakia to enable the delivery of business priorities and maintain highest standards of regulatory compliance and quality
• Dual reporting to cluster and LOC GMs. Advise LOC Management Teams (MT) on Regulatory matters and support MT business strategy.
• Builds, maintains and leads an efficient and well-motivated team ensuring appropriate prioritization and flexible resourcing including driving and measuring performance
• Leads the resource management, objective setting and review, development and coaching of staff.
• Ensure the development and optimization of standardized, efficient and compliant processes across the Czech Republic and Slovakia.
• Ensure compliant management of marketing authorizations.
• Ensure regulatory documentation are maintained according to internal procedure.
• Ensure local responsibilities relating to regulatory conformance are adhered to Regulatory Lead at audits and inspections
• Develop and maintain strong relationships with all key personnel within the Regulatory Agencies Local Industry groups and with key internal groups including those at a senior level in Global Regulatory, Safety and Medical.

Employee perks, benefits

• Stable and successful a leading global pharmaceutical company
• Excellent opportunity for personal and professional development
• Notebook and cell phone (also for personal use), company car
• Cafeteria - can be used for Multisport card, sport, culture, vacation, meal tickets
• Sickness benefit up to 80% of salary, Sick days
• Free vaccination also for family members
• Flexible working time, home-office
• 4 weeks holiday, plus loyalty holidays

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Personality requirements and skills

• University degree: Life sciences/pharmacy/professions aligned to medicine
• Knowledge of the policies and regulatory climate in the Czech Republic and Slovakia.
• A proven track record of effective collaboration and negotiation with regulatory agencies
• Advanced knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry.
• The ability to recognize, anticipate and discuss potential regulatory challenges with teams in the Business and Global Regulatory.
• Strong management and project leadership skills, ability to provide advice and counsel to company staff in strategic decisions;
• The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management

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Brief description of the company

Profile of GSK Group

GSK ( GlaxoSmithKline ) is a global scientific and medical company that operates in more than 115 countries . Our mission is to improve the quality of human life by enabling people to do more , feel better and live longer . We develop, manufacture and provide a wide range of innovative products for health and personal care .
We focus on :
• Medicines to treat wide variety of diseases
• Vaccines for children and adults to protect against infectious diseases
• Consumer products available in stores and pharmacies

GSK in Slovakia

The success of our company depends on the experience and motivation of our employees , so we are committed to their development. GSK offers its employees many opportunities for career development to enable them to work their best to develop their own potential and fulfill professional ambitions .
We support our employees in volunteer activities and as a company we devote a significant proportion of funds for charitable purposes , for which we have been named the Top Corporate Philanthropist .

GlaxoSmithKline Slovakia s.r.o. , Bratislava
GlaxoSmithKline Slovakia s.r.o. consists of divisions :
a) Pharmaceuticals aimed at graduation and distribution of a wide range of drugs mainly in the areas of respiratory diseases , cancerous diseases and the prevention of bacterial and viral infections - a vaccine
b ) Consumer Healthcare , within which combines the best from the world of daily consumer goods in categories - overall health , skin health , oral care and food and supplies to retail chains and pharmacies.

de Miclén s.r.o., a registered company of GSK , Levice
Stable , dynamically developing production plant in Levice , with nearly 600 employees , is part of the distribution network for GSK Consumer Healthcare . It focuses on the manufacture of personal care products in two divisions ( toothpaste and hair care ) , while part of the production is carried out under the name of our international contractors .

Number of employees

500-999 employees

Company address

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
821 04 Bratislava 2
http://www.gsk.sk


ID: 3591844   Dátum zverejnenia: 1.2.2019   Základná zložka mzdy (brutto) a ďalšie odmeny:   From 3500€ - the seniority of candidate will be taken into account in the job offer + annual bonus based on the ability to meet the company's targets