What are the responsibilities and job description for the Sr. Regulatory Affairs Manager position at Katalyst CRO?
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.
- 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.