Senior Regulatory Affairs Manager

Katalyst CRO; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Irvine, CA is seeking a Senior Regulatory Affairs Leader focused on quality-of-life products to develop regional regulatory strategies and lead a cross-functional team.

You will oversee regulatory submissions, interact with authorities, and align regional plans with global development objectives, traveling up to 10% internationally and domestically.

Join a dynamic regulatory group dedicated to advancing QOL therapies and ensuring compliance across regional markets.

Qualifications

• 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.

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.

Skills

Regulatory affairs

Cross-functional collaboration

Communication

Project management

Regulatory submissions

Education

Bachelor's degree in life sciences

Advanced degree preferred

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 to work independently and prioritize tasks effectively.
• Ability and willingness to travel approximately 10% of the year both domestically and internationally .