Senior Regulatory Affairs Manager

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO, located in Irvine, California, is seeking a Regulatory Affairs professional with over 5 years of experience in the pharmaceutical or biotech industry, particularly focusing on quality-of-life products. The role involves developing and executing regulatory strategies, preparing documents for authorities, and collaborating across teams to ensure compliance with regional regulations.

The ideal candidate will possess a Bachelor's degree in a scientific discipline, ideally with an advanced degree. Knowledge of FDA regulations and ICH guidelines is essential. Strong communication and analytical skills are required, along with the ability to work effectively in cross-functional teams.

Qualifications

• 5+ years of experience in regulatory affairs within pharmaceutical or biotech industry.
• Must have branded product regulatory affairs experience.
• Strong knowledge of FDA regulations and ICH guidelines.

Responsibilities

• Support the Senior Director in developing regulatory strategies for QOL initiatives.
• Prepare and submit regulatory documents to authorities.
• Collaborate with teams to integrate QOL considerations into product development.
• Manage regulatory risks and develop mitigation strategies as needed.

Skills

Regulatory affairs experience

Cross-functional teamwork

Communication skills

Analytical skills

Organizational skills

Education

Bachelor's degree in a scientific discipline

Advanced degree

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 regulatory 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.