Director Global Regulatory Affairs
vor 4 Wochen
Discover international are currently partnering with a pioneering pharmaceutical company committed to advancing groundbreaking therapies in Oncology. Specializing in the development of innovative treatments, we are expanding our team and seeking a highly skilled Regulatory Affairs Director with expertise in Oncology to lead regulatory efforts in Europe.
Responsibilities:
- European Regulatory Strategy:
- Develop and execute regulatory strategies for Oncology programs in compliance with European Medicines Agency (EMA) guidelines and requirements.
- Provide strategic regulatory guidance to support product development plans.
- Submission Management:
- Lead the preparation, compilation, and submission of regulatory documents for marketing applications and clinical trial approvals to European health authorities.
- Ensure timely and quality submissions in accordance with regulatory standards.
- Health Authority Interactions:
- Represent the company in interactions with European regulatory agencies, including participation in regulatory meetings and responses to inquiries.
- Establish and maintain positive relationships with regulatory authorities.
- Cross-functional Collaboration:
- Collaborate with cross-functional teams, including Clinical Development, Medical Affairs, and Quality Assurance, to integrate regulatory requirements into development plans.
- Ensure alignment between European regulatory strategies and corporate objectives.
Qualifications:
- Bachelor's degree in a relevant scientific discipline; advanced degree (Master's, Ph.D., or Pharm.D.) preferred.
- Minimum of 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, with a focus on Oncology in the European region.
- Proven track record of successful regulatory submissions and approvals for Oncology products in Europe.
- In-depth knowledge of European regulatory requirements and procedures for drug development.
- Excellent communication and interpersonal skills, with the ability to navigate cultural nuances in a European context.
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