Overview:
The Associate Director/Director, Regulatory Affairs - GDP, provides essential support to the Senior Director in overseeing regulatory activities related to Quality of Life (QOL) initiatives on a regional and/or global scale. This role involves assisting in the development and execution of regulatory strategies, regulatory submissions, and fostering collaboration with regional regulatory authorities. The Associate Director/Director will work closely with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes. This position plays a pivotal role in ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our QOL initiatives.
Responsibilities:
- Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions.
- Assist in providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
- Contribute to 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.
- Support in monitoring regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director.
- Assist in managing regulatory risks and opportunities related to QOL initiatives and contribute to 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 the Senior Director in serving as a subject matter expert on regional regulatory requirements, guidelines, and best practices related to QOL initiatives.
- Assist in coordinating 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 to senior and/or executive leadership and regulatory governance committees.
- Other duties as assigned.
Minimum Job Requirements:
Qualifications:
- Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
- 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred (oncology, obesity, and/or rare diseases). Level commensurate with 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.
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 significant managerial and 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 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 periods 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.
EEO:
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.
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