Bachelor's degree in scientific discipline; advanced degree preferred.
5+ years of experience in regulatory affairs, preferably within quality-of-life products.
Experience with branded product regulatory affairs required.
Strong understanding of FDA regulations and ICH guidelines.
Excellent communication and interpersonal skills.
Ability to develop regional regulatory strategies.
Strong organizational skills and attention to detail.
Responsibilities
Support the Senior Director in regional regulatory strategy development for quality of life (QOL) initiatives.
Contribute strategic oversight and leadership to the regulatory team for alignment with company objectives.
Prepare and submit regulatory documents for QOL initiatives to authorities.
Collaborate with teams to integrate QOL considerations into product development and commercialization.
Foster relationships with regulatory authorities to facilitate communication on QOL initiatives.
Stay updated on regulatory developments and provide insights to leadership.
Assist in managing regulatory risks and developing mitigation strategies.
Benefits
Opportunity for professional development and advancement within the company.
Collaborative work environment with cross-functional teams.
Involvement in impactful quality-of-life initiatives.
Exposure to regulatory authorities and industry forums.
Potential for travel, fostering global experience.
Full 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.
ssist 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.
ssist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees.
ssists 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.
bility to assist in developing and executing regulatory strategies tailored to specific regions.
Strong organizational skills with attention to detail.
bility to collaborate effectively with cross-functional teams.
Knowledge of regulatory submissions and documentation processes.
wareness of regulatory developments and trends within specific regions.
Strong analytical and problem-solving skills.
bility to work independently and prioritize tasks effectively.
bility and willingness to travel approximately 10% of the year both domestically and internationally
