Biotechnology Regulatory Affairs Manager

If you are a highly motivated and experienced Regulatory Affairs Manager looking to join a dynamic and innovative biotechnology company, we encourage you to apply for this exciting opportunity.

Job Title: Biotechnology Regulatory Affairs Manager

Location: Graz, Austria

Salary: DOE

Employment Type: Full-time

Experience Level: Mid-Senior level

Industry: Biotechnology

About the Role: We are seeking a highly skilled and experienced Biotechnology Regulatory Affairs Manager to join our dynamic team. As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with all regulatory requirements for the development, registration, and commercialization of our biotechnology products. You will be responsible for managing the regulatory affairs team, as well as collaborating with cross-functional teams to ensure timely and successful product approvals.

Key Responsibilities:

• Develop and implement regulatory strategies for the development, registration, and commercialization of biotechnology products in compliance with local and international regulations
• Manage and lead a team of regulatory affairs professionals, providing guidance, training, and support to ensure the team's success
• Serve as the primary point of contact for all regulatory agencies, representing the company's interests and responding to inquiries and requests for information
• Conduct thorough reviews of all regulatory submissions, including INDs, NDAs, and BLAs, to ensure accuracy and compliance with regulatory requirements
• Stay up-to-date with all changes in relevant regulations and guidelines, communicating any potential impacts to the company and developing appropriate strategies for compliance
• Collaborate with cross-functional teams, including research and development, clinical, and commercial teams, to ensure alignment and timely execution of regulatory strategies
• Prepare and submit all necessary regulatory submissions, including amendments, supplements, and annual reports, to regulatory agencies
• Manage relationships with external partners, including contract research organizations and consultants, to ensure timely and high-quality delivery of regulatory submissions and approvals
• Participate in regulatory agency meetings and negotiations, providing expert advice and guidance on all regulatory matters
• Support the development and implementation of regulatory training programs for internal teams to ensure compliance with regulations and guidelines
• Develop and maintain strong relationships with key stakeholders, including regulatory agencies, industry associations, and other relevant organizations

Qualifications:

• Bachelor's or higher degree in a relevant scientific discipline
• Minimum of 5 years of experience in regulatory affairs within the biotechnology industry
• Proven experience in managing and leading a team of regulatory professionals
• Strong knowledge of local and international regulations and guidelines for the development, registration, and commercialization of biotechnology products
• Experience preparing and submitting regulatory submissions, including INDs, NDAs, and BLAs
• Excellent communication and interpersonal skills, with the ability to effectively communicate complex regulatory information to a variety of audiences
• Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously
• Ability to work independently and collaboratively in a fast-paced, dynamic environment
• Strong attention to detail and excellent problem-solving skills
• Proficiency in relevant software and tools, such as eCTD, EDMS, and MS Office Suite

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development within our organization.