Derks vacature regulatory-affairs

Labelling Manager ROW

Derks & Derks

Temporary position for 12 months in Labelling for the Rest-of-the-World (ROW) region, in particular Latin America

Offer
  • a quality orientated organisation in the pharmaceutical industry
  • working in an international environment
  • a temporary contract or an independent contract from Derks & Derks Secondment & Interim
  • a contract for 12 months with the possibility to extend
Position

As a Labelling Manager ROW you will be responsible for the development, implementation, and change control of new and revised labelling for assigned products and areas within the Rest-of-World (ROW) region and in particular Latin America. You ensure compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. You will perform research government initiatives related to labelling and packaging and assure that the organisation adopts new initiatives according to prescribed timelines. Also, this position requires significant interaction outside the Regulatory Affairs department on complex issues and questions. You will maintain a positive working relationship with global and internal stakeholders and business partners. You will be joining an international team and your manager is based in the Netherlands.

Profile
  • Bachelor’s degree
  • at least 6 years previous industry experience; 3 in RA
  • direct pharmaceutical labelling development experience required with demonstrated proficiency in managing change control
  • proven proficiency with relevant FDA/ICH and other local health authority regulations & guidelines for labelling development, implementation, and compliance requirements, and applied understanding to business situations
  • good communication skills in English and a second language

 

Organisation

The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They have everything in house like research, development, manufacturing, warehousing, but also sales and marketing. It is their hope to change tomorrow and to improve the lives of individuals by providing innovative medicines in areas of health where there is an urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. At this moment they are open to meet an enthusiastic candidate for a temporary position as Labelling Manager at their office in Leiden.

 

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/22-069, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Tagged as: Life Sciences

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