Senior Regulatory Affairs Manager - Katalyst Healthcares and Life Sciences : Job Details

Senior Regulatory Affairs Manager

Katalyst Healthcares and Life Sciences

Job Location : Houston,TX, USA

Posted on : 2025-08-05T08:19:56Z

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 scientific disciplines such as life sciences, pharmacy, bioscience; advanced degree preferred.
  • 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a preferred focus on quality-of-life products.
  • 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.
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