Position Overview: We are seeking an experienced and strategic Associate Director of Regulatory Affairs to join our pipeline of dynamic sciences candidate talent. In this type of role you will provide leadership and expertise in managing clinical regulatory filings and guiding project teams through the go-to-market process for innovative science-driven products. The ideal candidate will have a strong background in regulatory submissions, project management, and cross-functional collaboration within the life sciences industry.

Key Responsibilities:

· Regulatory Strategy and Submissions:

• Develop and execute regulatory strategies to support clinical development and product approval.
•  Prepare, review, and submit regulatory filings, including INDs, NDAs, BLAs, PMAs, and other clinical regulatory documentation.
•  Ensure compliance with global regulatory requirements and maintain up-to-date knowledge of relevant regulatory guidelines.

· Project Leadership:

• Lead cross-functional project teams, providing regulatory guidance and strategic direction to support go-to-market initiatives.
•  Collaborate with R&D, clinical operations, quality assurance, and marketing teams to ensure alignment with regulatory goals.
•  Monitor project milestones and timelines, addressing potential regulatory hurdles proactively.

· Stakeholder Communication:

• Serve as the primary point of contact with regulatory agencies, facilitating communications, meetings, and negotiations.
•  Communicate regulatory requirements and updates to internal stakeholders, fostering a clear understanding of expectations.

· Risk Management:

•  Identify and assess regulatory risks associated with clinical and go-to-market projects.
•  Develop mitigation strategies to address potential challenges and ensure smooth progression through regulatory pathways
• · Leadership and Mentorship:
• Provide mentorship and guidance to junior regulatory team members, fostering professional growth and knowledge sharing.
•  Contribute to the development of departmental processes, tools, and best practices to enhance operational efficiency.

Required Qualifications:

· Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.

· 8+ years of experience in regulatory affairs within the life sciences industry, with a focus on clinical regulatory filings.

· Proven track record of successful submissions and interactions with regulatory agencies (e.g., FDA, EMA, etc.).

· Strong understanding of global regulatory requirements, including ICH guidelines and GCP standards.

· Excellent project management and leadership skills, with the ability to influence and drive cross-functional teams.

· Exceptional written and verbal communication skills.

Preferred Qualifications:

· Regulatory Affairs Certification (RAC) or equivalent credential.

· Experience with combination products, biologics, or advanced therapies.

· Familiarity with regulatory considerations for digital health or AI-driven medical products.

Why Join Us? This is an exciting opportunity to play a key role in bringing groundbreaking life sciences products to market. As an Associate Director of Regulatory Affairs, you will have the chance to lead impactful projects, engage with global regulatory agencies, and contribute to improving patient outcomes through innovation.