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. Come to work for a company that belongs to a TOP "MODERN EMPLOYER" companies on the Czech market.
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.

Requirements

• 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

We offer

• 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 sport, culture, vacation, meal tickets, financial products and other
• Sickness benefit up to 80% of salary, Sick days
• Free vaccination (within company vaccines portfolio)
• Flexible working time, home-office
• 6 weeks holiday, plus loyalty holidays

Informace o pozici

Místo pracoviště

Hvězdova 1734/2c, 140 00  Praha-Nusle, Česká republika

Typ pracovního vztahu

Práce na plný úvazek

Typ smluvního vztahu

Pracovní smlouva

Délka pracovního poměru

Na dobu neurčitou

Benefity

Firemní akce, flexibilní začátek/konec pracovní doby, individuální rozvržení pracovní doby, možnost občasné práce z domova, dovolená více než 5 týdnů, možnost delšího neplaceného volna, nadstandardní lékařská péče, zdravotní volno/sickdays, bonusy/prémie, kafetérie, manažerský motivační program, příspěvek na penzijní/životní připojištění, příspěvek na sport/kulturu/volný čas, auto i pro soukromé účely, mobilní telefon, notebook, občerstvení na pracovišti, stravenky/příspěvek na stravování

Požadované vzdělání

Vysokoškolské / univerzitní

Požadované jazyky

Angličtina (pokročilá)

Zadavatel

GLAXOSMITHKLINE, s.r.o.

 

Kontakt

GLAXOSMITHKLINE, s.r.o.
Lenka Kubičárová
Hvězdova 1734/2c
140 00  Praha - Nusle
Česká republika
Telefon: 778 486 341