Sr. Regulatory Affairs Manager

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

Responsibilities

• Support the Senior Director in developing and executing regional regulatory strategies for QOL
• initiatives within specific regions.
• Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
• Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities.
• Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes.
• Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives.
• Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director.
• Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed.
• Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives.
• Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives.
• Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
• Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees.
• Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives.
• Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.

Requirements

• Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
• 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred.
• Must have branded product reg affairs experience
• Demonstrated ability to work effectively in a cross-functional team environment.
• Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines.
• Excellent communication and interpersonal skills.
• Ability to assist in developing and executing regulatory strategies tailored to specific regions.
• Strong organizational skills with attention to detail.
• Ability to collaborate effectively with cross-functional teams.
• Knowledge of regulatory submissions and documentation processes.
• Awareness of regulatory developments and trends within specific regions.
• Strong analytical and problem-solving skills.
• Ability to work independently and prioritize tasks effectively.
• Ability and willingness to travel approximately 10% of the year both domestically and internationally