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.
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.
Lily Savage
Associate Director
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