Regulatory Affairs Manager - Clinical Research - 237945

About This Opportunity:

We are looking for a Manager of Regulatory Affairs to join our wonderful team of

motivated research professionals. The Manager of Regulatory Affairs will be responsible for leading and overseeing the regulatory strategy and execution for clinical trials across all phases of development This role ensures compliance with cross-functional teams to achieve successful regulatory submissions and approvals. The main responsibilities are:

Regulatory Strategy Development:

• Develop and implement comprehensive regulatory strategies for clinical trials across multiple therapeutic areas.
• Provide regulatory guidance on clinical trial design, protocol development, and regulatory submissions.
• Anticipate and assess regulatory risks and develop mitigation strategies.

Regulatory Submissions:

• Lead the preparation, review, and submission of regulatory documents (e.g., INDs, CTAs, amendments, and annual reports) to global regulatory authorities.
• Oversee the compilation and submission of regulatory documents for clinical trial applications, ensuring compliance with regulatory requirements and timelines.
• Manage interactions with regulatory agencies, including leading meetings and negotiations.

Compliance and Quality Assurance:

• Ensure that all clinical trials comply with applicable regulatory requirements, including ICH GCP guidelines, FDA regulations, EMA guidelines, and other international standards.
• Monitor changes in regulatory requirements and communicate their impact on ongoing and future clinical trials.
• Collaborate with the Quality Assurance team to ensure adherence to regulatory standards and best practices.

Cross-Functional Collaboration:

• Work closely with clinical operations, medical affairs, biostatistics, and other departments to align regulatory strategies with clinical development plans.
• Provide regulatory expertise to cross-functional teams and contribute to the development of clinical and regulatory documents (e.g., protocols, informed consent forms, clinical study reports).

Team Leadership and Development:

• Lead and mentor a team of regulatory professionals, fostering a culture of excellence and continuous learning.
• Oversee the performance management and professional development of team Members.
• Collaborate with senior management to establish departmental goals and Objectives.

Regulatory Intelligence:

• Stay current on global regulatory trends, guidance, and industry practices.
• Conduct regulatory intelligence to inform strategic decision-making and ensure competitive advantage.
• Represent the company at industry conferences and regulatory forums.
• The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree (PhD, PharmD, MS) preferred.
• 3-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on clinical trials.
• Demonstrated experience in leading regulatory strategy and submissions for clinical trials across multiple regions. In-depth knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
• Strong leadership skills with experience managing and developing teams.
• Excellent communication, negotiation, and project management skills.
• Ability to work effectively in a fast-paced, cross-functional environment.
• Proven ability to manage multiple projects and meet deadlines.
• Please note that due to the immunocompromised nature of our patients,
• COVID and annual flu vaccinations are required.

Hours: 8-4:30 M-F