Job-ID31716410Reference26-00055 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 and willingness to travel approximately 10% of the year both domestically and internationally
...Elective spine and general ortho call -- inpatient/outpatient ~ Hospital privileges required ~ Paid malpractice insurance; pre-paid travel and housing expenses ~ Assignment details and time entry in online portal ~ Competitive compensation ~24-hour access to your...
...AFSCME Council 57 Union Representative Based in California AFSCME District Council 57 is currently interviewing for Union Representative positions. Our Council covers over 35,000 members in 27 local unions throughout California in the northern, central region...
...Job Overview The role of the Teacher-Mentor is the high calling to sacrificially serve the next generation of our city through executing the complete model of Elevate Indianapolis by investing outside the school day, life-on-life year-round mentoring, and virtually year...
...Parking Enforcement Officer (Full-Time) The Revenue Authority of Prince George's County has openings for our Parking Enforcement Officer position. We are seeking enthusiastic individuals for this full-time opportunity who can work the evening shift, Tuesday- Saturday...
...Job Description Job Description Department Head - Clothing & Houseware Department Our Perfect Match: We are looking for someone who loves to merchandise various products, loves to communicate with customers & likes to have fun at work, while getting things done...