Regulatory Affairs Director (CMC)

Regulatory Affairs Director (CMC)

PPD - Pharmaceutical Product Development

Brussels, Belgium

 

In this leadership role, you will provide innovative solutions, technical CMC expertise and guidance. You will be involved in client interface and relationship building, and project management with key delivery on regulatory projects with a CMC component.

The following skills are required to be successful in this role:

  • Demonstrated leadership skills, matrix management or line management;
  • Proven project management, negotiation and communication skills;
  • Strong technical skills and in-depth knowledge of regulatory CMC in the region.

Qualifications

Education and Experience:

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years’) or equivalent combination of education, training, & experience;
  • Significant regulatory CMC experience in the EMEA region;
  • Written and Verbal French and English language skills.

Knowledge, Skills and Abilities:

  • Proven experience in business development activities and networking;
  • English language as well as local language where applicable;
  • Excellent interpersonal skills;
  • Effective oral and written communication skills;
  • Excellent organizational and planning skills;
  • Excellent negotiation skills;
  • Ability to work on own initiative;
  • Proven ability to work effectively in a team environment;
  • Ability to motivate and integrate teams and teach/mentor team members;
  • Good knowledge of global/regional/national country requirements/Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management;
  • In-depth knowledge of CMC;
  • Ability to discipline and reward employees and perform timely, effective performance evaluations;
  • Good judgement and decision-making skills.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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