The Senior Manager, 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. While providing valuable support to higher-level management, the Senior Manager focuses on executing regulatory tasks, 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.
• 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.
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• 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.
• 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

• This position has no decision-making authority.
• 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

Essential Physical and Mental Requirements

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.