Senior Manager Regulatory Affairs

Overview

We are seeking a highly skilled and experienced Senior Manager of Regulatory Affairs to join our European-based small size biotechnology research company. The successful candidate will play a key role in ensuring compliance with regulatory requirements and driving the regulatory strategy for our innovative products.

Responsibilities

• Develop and implement regulatory strategies for product development and approval in European markets.
• Oversee the preparation and submission of regulatory documents to health authorities.
• Provide regulatory guidance to cross-functional teams and ensure compliance with regulations and standards.
• Stay updated on changes in regulatory requirements and assess the impact on the company's products and processes.
• Represent the company in interactions with regulatory agencies and industry associations.

Qualifications

• Bachelor's degree in a scientific discipline, advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry.
• In-depth knowledge of European regulatory requirements and procedures.
• Proven track record of successful regulatory submissions and approvals.
• Strong leadership and communication skills.

Day-to-day

• Collaborate with internal teams to align regulatory strategies with business goals.
• Review and interpret regulatory guidelines and communicate implications to stakeholders.
• Lead regulatory meetings and provide guidance on regulatory issues.
• Monitor and assess the impact of regulatory changes on ongoing projects.

Benefits

• Competitive salary and benefits package.
• Opportunity to work in a dynamic and innovative biotechnology research environment.
• Chance to make a significant impact on the regulatory strategy of cutting-edge products.
• Professional development and growth opportunities within the company.

If you are a seasoned regulatory affairs professional with a passion for driving regulatory excellence in a fast-paced biotechnology environment, we encourage you to apply for this exciting opportunity.

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