Regulatory Affairs Lead

vor 4 Wochen

Berlin, Berlin, Deutschland GULP – experts united Vollzeit

At GULP – experts united, we are seeking a qualified Regulatory Affairs Manager to join our team. This role is essential for navigating the complexities of the pharmaceutical industry. We are committed to fostering an inclusive environment and welcome applications from individuals with disabilities.

What we offer:

  • Competitive salary package based on qualifications and experience
  • Comprehensive social benefits, including vacation and holiday bonuses
  • Typically, a permanent employment contract
  • Dedicated support from our team at the branch office
  • Opportunities for skills development through various e-learning programs

Your responsibilities:

  • Formulate, align, and execute approval strategies to ensure timely submissions and successful first-cycle approvals for assigned development projects globally
  • Evaluate and align the probability of success for the assigned development projects
  • Engage with stakeholders to present and align regulatory strategies and success probabilities
  • Collaborate with health authorities to present, validate, and negotiate development plans and product labeling
  • Devise regulatory strategies for assigned projects by assessing and designing options on both regional and global levels
  • Establish local and global regulatory project objectives from development through to life cycle management
  • Prepare submission documents for local and global submissions, oversee the review process, and ensure compliance with local and global health authority regulations
  • Lead a global regulatory team and coordinate regulatory contributions to the global development plan of assigned projects

Your qualifications:

  • Advanced technical degree (Ph.D., DVM, or Pharm D.) in life sciences, with several years of medical research experience, including local and global regulatory experience in a related therapeutic area; alternatively, a Master's or Bachelor's degree with relevant experience
  • In-depth knowledge of regional health authority regulations and advanced understanding of global regulations, with proven interaction with local health authorities
  • Demonstrated leadership and project management capabilities, including effective cross-functional communication and interpersonal skills
  • Ability to discuss and address issues related to product safety and pharmaceutical regulatory compliance
  • Fluency in both written and spoken German and English
  • Strong verbal and written communication skills, along with excellent analytical abilities

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