Senior Manager/Associate Director, Regulatory Affairs - GDP

The Senior Manager/Associate Director, Regulatory Affairs -GDP - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional regulatory authorities. The Senior Manager/Associate Director will integrate multiple inputs from the global regulatory team (GRT) members to create unified global regulatory strategies, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for our QOL initiatives.

• 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.

• Coordinate and document GRT meetings to develop global marketing authorization submission plans and timing

• Participate in other teams (clinical, labeling working group, etc.) in making strategic decisions, including creation of labeling strategy

• Represent regulatory affairs on the product development team and provide regulatory recommendations and directions associated with proposed strategies

• Provide regulatory input and assist in the preparation and submission of regulatory dossiers to Health Authorities (NDA/MAA/IND, etc.)

• Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes.

• Assist in preparing communications for health authorities to facilitate meetings, negotiations, and interactions related to QOL initiatives.

• Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the cross-functional team.

• 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.

• Other duties as assigned.

Minimum Job Requirements

Qualifications

• Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience, or other relevant discipline; 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.

• 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.

Competencies

• 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.

Other Requirements

• Ability and willingness to travel approximately 10% of the year both domestically and internationally

• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Additional Information

The base salary range for this full-time position is $135,000 - $185,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.