Biotechnology Regulatory Affairs Manager

At BioTech Enterprises, we value innovation, collaboration, and a passion for making a difference in the lives of patients. If you are a self-starter with a strong background in biotechnology regulatory affairs, we encourage you to apply for this exciting opportunity.

Title: Biotechnology Regulatory Affairs Manager

Location: Tartu, Estonia

Company: BioTech Enterprises

Industry: Biotechnology

Position Type: Full-time

Salary: Market rate

Job Description: BioTech Enterprises is seeking a highly motivated and experienced Biotechnology Regulatory Affairs Manager to join our dynamic team. As a leader in the biotechnology industry, we are committed to developing innovative products that improve the lives of patients worldwide. As a Regulatory Affairs Manager, you will play a critical role in ensuring our products meet all regulatory requirements and are in compliance with applicable laws and regulations.

Responsibilities:

• Develop and implement regulatory strategies for new and existing products, including submissions to regulatory authorities such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
• Monitor and interpret changes in regulatory requirements and communicate any potential impact to the organization.
• Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documents.
• Prepare and review regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
• Act as the primary point of contact for regulatory agencies, including responding to inquiries and requests for additional information.
• Conduct regulatory risk assessments and advise on potential risks and mitigation strategies.
• Participate in internal and external audits to ensure compliance with regulatory requirements.
• Stay current on industry best practices and regulatory guidelines to ensure continuous improvement of regulatory processes.
• Train and mentor junior regulatory affairs team members.

Qualifications:

• Bachelor's degree in a scientific or related field, advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the biotechnology industry.
• Strong understanding of FDA and EMA regulations and guidelines.
• Experience with the submission and approval process for INDs, NDAs, and MAAs.
• Excellent communication skills, both written and verbal.
• Strong attention to detail and ability to manage multiple projects simultaneously.
• Proven ability to work effectively in a cross-functional team environment.
• Experience with regulatory risk assessments and developing mitigation strategies.
• Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations.
• Ability to adapt to changing priorities and work under tight timelines.
• Strong leadership skills and experience mentoring junior team members.

Join our team and be a part of our mission to improve human health through groundbreaking biotechnology products.