Junior Director Regulatory Affairs - PureTek Corporation

The Director of Regulatory Affairs will be responsible for overseeing and directing all regulatory activities to ensure compliance with global regulatory requirements and to support the company’s business objectives. This position will play a critical role in regulatory submissions, strategy, and interactions with regulatory agencies.

Key Responsibilities:

• Develop and implement regulatory strategies to ensure successful approval of new products and maintenance of existing product licenses.
• Lead the preparation, submission, and management of regulatory filings (INDs, NDAs, ANDAs, BLAs, MAAs) to regulatory agencies including FDA, EMA, and other global authorities.
• Maintain current knowledge of regulatory requirements and ensure company compliance with applicable laws, regulations, and guidelines.
• Serve as the primary contact with regulatory agencies, managing all communications and interactions.
• Provide regulatory guidance to cross-functional teams, including R&D, Quality, Clinical, and Marketing.
• Oversee the compilation and submission of regulatory documentation, ensuring accuracy and completeness.
• Develop and implement regulatory policies, procedures, and best practices.
• Train and mentor regulatory affairs staff to enhance their professional development.
• Monitor and analyze regulatory developments and communicate potential impacts to senior management and relevant departments.
• Participate in strategic planning and decision-making processes as a member of the senior leadership team.

Qualifications:

• Bachelor’s degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.); advanced degree preferred.
• Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, with at least 5 years in a leadership role.
• Comprehensive knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
• Proven track record of successful regulatory submissions and approvals.
• Strong leadership and management skills, with the ability to lead and develop a high-performing team.
• Excellent written and verbal communication skills, with the ability to effectively interact with regulatory authorities and cross-functional teams.
• Detail-oriented with strong organizational and project management skills.
• Ability to work independently and collaboratively in a fast-paced environment.