Aktualnie prowadzone rekrutacje

With offices in Berlin, Warsaw and Prague, KCR Placement is an international boutique provider of ‘fit for purpose’ resourcing solutions for a wide array of functions, including expert, managerial and senior executive ones. We specialize in finding the right talents for Pharmaceutical, Biotech, Medical Device companies and Contract Research Organizations across Europe. 


We're onboarding best-in-class candidates, so give us a chance to meet you!

Current Vacancy Highlights:

Associate Director Regulatory Affairs EMEA – OTC

KCR Placement on behalf of the Client, top pharmaceutical producer, one of Global Top 20 is searching for suitable candidates for R&D division for the position of:

 

 
Associate Director Regulatory Affairs EMEA – OTC
 

 

Location: Warsaw

 

Reporting to: Director of Regulatory Affairs – Europe, Middle East and Africa (EMEA)

Direct team reporting: up to 5 people

 

Range of duties:

  • Manage and execute Regulatory activities across EMEA within OTC brand categories to meet Commercial/Regulatory requirements for Company.
  • Develop OTC regulatory strategies and formulate registration plans.
  • Manage EMEA Regulatory functions as these relate to OTC, to provide a proactive, cost effective, efficient and competent regulatory affairs service dedicated to meeting the needs of its European and World-wide customers.
  • Proactive and credible business partner to EMEA Franchise and in-market business colleagues.
  • Provide regulatory strategies to guide Global New Product Development and contribute to Global Regulatory process development for OTC products.
  • Ensure proactive compliance of all licences and responsibilities

To ensure the development of EMEA Regulatory strategies for OTC products to meet business needs:

 

Determine and manage resources to execute regulatory activities in support of EMEA OTC Brand Plans

  • Align with EMEA OTC Franchise to identify and set project timings and ensure appropriate EMEA resource is available to execute appropriately.
  • Support continuous improvement in regulatory knowledge.

 

Use regulatory knowledge to execute regulatory activities in support of EMEA OTC Brand plans

  • Partner with EMEA Medical Affairs Category/Global R&D to develop European R&D plans in support of Franchise and brand objectives.

 

Lead multiple projects and represent the function as a prime internal Regulatory contact 

  • Dependent upon business priorities take regulatory leadership role on specified projects.
  • Provide Local/Regional Regulatory feedback on all global initiatives to ensure all EMEA regulatory requirements for OTC products are understood at a Global level.

 

Develop and input to EMEA Brand plans for OTC products by understanding and shaping the external environment

  • Provide a regulatory intelligence support service to Regulatory personnel in line with project responsibilities
  • Proactively represent Company in external Industry Bodies, where appropriate.

Undertake Change Management activities to ensure the continuous evolution of the EMEA Regulatory Affairs OTC function

  • Update and create working practices for processes used in EMEA Regulatory Affairs for OTC products.
  • Train, where appropriate, new starters in Regulatory Affairs.
  • Assess the relevance of new technologies and products to Regulatory Affairs.
  • Provide regulatory guidance to colleagues.

 

Educational Requirements:

  • Minimum Life Science Degree or equivalent qualification.

 

Minimum Experience Required:

  • 7+ years of progressive experience in European Regulatory Affairs, in particular good working knowledge of the European procedures (Mutual Recognition and Decentralised procedure)
  • Experience in OTC (non-prescription) essential
  • Regional and country regulatory experience essential, global experience desirable
  • Experience of switch and other areas such as Rx, medical device, cosmetics or food would be desired
  • Demonstrate excellent leadership, people management and communication skills.
  • Demonstrate strong organisational skills, including the ability to prioritise workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific and manufacturing.
  • Strong sensitivity for multi-cultural/multi-National environments.
  • Well organised, detail-oriented, effective in written and oral communication.
  • Ability to undertake financial management.
 
We’re onboarding “best in class” candidates, so give us a chance to meet you!
 

NOTE:

By sending your personal data to KCR Placement in a broader extent than required by art. 22 (1) of the Polish Labor Code, you give KCR Placement your consent to the data processing for the purpose of ongoing recruitment process.

The consent can be withdrawn at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

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