Senior Manager, Regulatory Affairs, CMC

Overview

The Senior Manager, Regulatory Affairs CMC  supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination for Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities. In support of CMC activites, this role is responsible for collaborating closely with cross-functional teams and regulatory authorities to ensure compliance and drive the success of Shionogi’s pipeline products and initiatives.

Responsibilities

• Collaborate with the Senior Director and cross-functional teams to develop and implement regulatory strategies for CMC aspects of product development. This involves assessing regulatory requirements and guidelines and aligning strategies with business objectives.
• Oversee the preparation, review, and submission of CMC-related documents for regulatory filings, such as INDs, NDAs, and MAAs. Ensure submissions are of high quality, compliant with regulatory requirements, and submitted within established timelines.
• Serve as a key point of contact for regulatory agencies regarding CMC-related inquiries, meetings, and submissions. Communicate effectively with regulatory authorities, address queries, and negotiate regulatory matters under the guidance of the Senior Director.
• Work closely with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment of CMC regulatory requirements with overall product development plans and timelines. Facilitate communication and collaboration among team members to achieve regulatory milestones.
• Stay updated on global regulatory requirements, guidelines, and industry trends related to CMC regulatory affairs. Assess the impact of regulatory changes on product development activities and propose appropriate actions to maintain compliance.
• Maintain accurate and up-to-date documentation of regulatory activities, including submission records, correspondence with regulatory agencies, and regulatory intelligence. Ensure compliance with document retention policies and regulatory standards.
• Identify and assess risks related to CMC regulatory affairs and develop mitigation strategies in collaboration with the Senior Director and relevant stakeholders. Proactively address potential regulatory issues to minimize impact on product development timelines.
• Provide support to the Senior Director in various activities, such as preparing for regulatory meetings, conducting regulatory assessments, and contributing to strategic decision-making related to CMC regulatory affairs.
• Other duties as assigned.

Minimum Job Requirements 

 

• Bachelor's degree in a scientific or related field; advanced degree (e.g., MSc, PhD, PharmD) preferred.
• Minimum of five (5) years of experience in regulatory affairs, with a focus on CMC regulatory affairs in the pharmaceutical industry.
• Strong understanding of global regulatory requirements and guidelines related to CMC aspects of pharmaceutical product development (e.g., FDA, EMA, ICH).
• Excellent communication skills, both verbal and written, with the ability to effectively convey complex regulatory concepts to diverse audiences.
• Demonstrated ability to collaborate effectively with cross-functional teams and external stakeholders to achieve regulatory milestones and drive product development initiatives forward.
• Meticulous attention to detail and strong analytical skills, with the ability to review and prepare regulatory documentation accurately and ensure compliance with regulatory requirements.
• Proven ability to adapt to changing priorities and timelines in a fast-paced, dynamic environment while maintaining focus on key objectives and delivering high-quality results.
• Ethical conduct and commitment to upholding integrity and transparency in all regulatory activities and interactions.
• Continuous learning mindset and willingness to stay updated on regulatory trends, updates, and best practices in CMC regulatory affairs through ongoing professional development.
• Ability to travel via automobile and/or airplane.
• Hybrid work arrangements will allow work from home combined with your presence on-site 2-3 days/week (when not traveling) at our US HQ in Florham Park, NJ.  

Competencies

• Understanding of global regulatory requirements, guidelines, and processes related to CMC aspects of pharmaceutical product development, including FDA, EMA, and ICH regulations.
• Ability to develop and implement strategic regulatory plans aligned with business objectives, considering the regulatory landscape, competitive environment, and product lifecycle.
• Strong verbal and written communication skills to effectively communicate with internal stakeholders, regulatory agencies, and cross-functional teams. Ability to convey complex regulatory concepts in a clear and concise manner.
• Demonstrated ability to collaborate effectively with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to achieve regulatory milestones and drive product development initiatives forward.
• Strong analytical and problem-solving skills to identify regulatory issues, assess risks, and develop practical solutions in a fast-paced and dynamic environment.
• Meticulous attention to detail in reviewing and preparing regulatory documentation, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Ability to adapt to changing regulatory requirements, priorities, and timelines while maintaining focus on key objectives and delivering high-quality results.
• Demonstrated leadership capabilities, even without direct reports, to influence and guide cross-functional teams towards regulatory compliance and successful product development outcomes.
• Proactive approach to staying abreast of regulatory trends, updates, and best practices in CMC regulatory affairs, and ability to apply this knowledge to enhance regulatory strategies and processes.
• Commitment to upholding ethical standards and compliance with regulatory requirements, maintaining integrity and transparency in all regulatory activities and interactions.
• Basic project management skills to effectively prioritize tasks, manage timelines, and coordinate activities across multiple projects simultaneously.
• Willingness and enthusiasm for continuous learning and professional development in the field of regulatory affairs, including pursuing relevant certifications or advanced training opportunities.

Additional Information

The base salary range for this full-time position is $140,000 - $170,000. 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. 

EEO

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.

 

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