Strategic Regional Regulatory Lead - QOL Initiatives

Katalyst CRO; Boulder (CO); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO in Boulder, CO, seeks a Regulatory Affairs professional to develop and execute regional regulatory strategies for QoL initiatives, support submissions to authorities, and align regulatory with product development and manufacturing.

The role requires 5+ years in regulatory affairs, branded product experience, cross-functional collaboration, FDA/ICH knowledge, and excellent communication; travel up to 10% internationally.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 5+ years in regulatory affairs in pharma/biotech, with focus on QoL products.
• Must have branded product regulatory affairs experience.
• Strong cross-functional teamwork.
• Knowledge of FDA and ICH guidelines.
• Excellent communication and interpersonal skills.
• Ability to travel ~10% domestically and internationally.

Responsibilities

• Assist in developing and executing regional regulatory strategies for QoL initiatives.
• Provide strategic oversight and leadership to the regulatory team; ensure alignment with company objectives and regional regulatory requirements.
• Prepare and submit regulatory documents related to QoL initiatives to regulatory authorities.
• Collaborate with cross-functional teams to integrate QoL considerations into product development, manufacturing, and commercialization.
• Foster relationships with regional regulatory authorities to facilitate communications and negotiations.
• Stay informed about regulatory developments and provide insights to leadership.
• Contribute to managing regulatory risks and develop mitigation strategies as needed.
• Provide regulatory guidance for post-marketing activities including variations, renewals, labeling updates, and compliance initiatives.
• Represent the company's regulatory interests in industry forums and regulatory meetings.
• Coordinate with global regulatory counterparts to align regional strategies and submissions with global plans.
• Prepare regulatory updates and strategic recommendations for leadership and governance committees.
• Assist in documentation for regulatory inspections and inspection readiness.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy development

Regulatory knowledge (FDA/ICH)

Communication skills

Travel readiness

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

5+ years regulatory affairs experience

Job description

Katalyst CRO in Boulder, CO, seeks a Regulatory Affairs professional to develop and execute regional regulatory strategies for QoL initiatives, support submissions to authorities, and align regulatory with product development and manufacturing.

The role requires 5+ years in regulatory affairs, branded product experience, cross-functional collaboration, FDA/ICH knowledge, and excellent communication; travel up to 10% internationally.