Sr. Regulatory Affairs Manager

Katalyst CRO; Dallas (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

Katalyst CRO seeks a Senior Director of Regulatory Affairs to lead regional QOL regulatory strategies in the US and globally. The role partners with cross-functional teams to ensure alignment with FDA and ICH guidelines and to drive submissions and inspections readiness.

The candidate will guide regional strategies, manage regulatory risks, and provide strategic oversight to the regulatory team. Travel up to 10% domestically and internationally is required.

Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred.
• Minimum 5+ years in regulatory affairs within pharma/biotech with branded products experience.
• Strong knowledge of FDA regulations and ICH guidelines; global submission experience beneficial.

Responsibilities

• Lead regional regulatory strategies for QOL initiatives; provide strategic oversight.
• Support submission planning and regulatory document preparation for QOL programs.
• Collaborate cross-functionally to integrate regulatory considerations into development and manufacturing.
• Engage with regional authorities to negotiate and communicate on QOL initiatives.
• Monitor regulatory developments and advise leadership on risks and opportunities.
• Support post-marketing activities including variations, renewals, and labeling updates.
• Ensure inspection readiness and prepare documentation for regulatory inspections.
• Coordinate with global counterparts to align regional submissions with global plans.

Skills

Cross-functional leadership

Regulatory strategy development

FDA & ICH knowledge

Effective communication

Travel coordination

Education

Bachelor's in life sciences

Advanced degree (MS/PhD)

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