Senior Manager Associate Director, Regulatory Affairs CMC

The Senior Manager/Associate Director Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing global CMC regulatory strategies for assigned investigational and/or marketed assets. The role partners closely with technical quality supply and program teams to communicate regulatory strategies and deliver scientifically sound submission ready CMC content using a risk based approach. This individual demonstrates exceptional scientific writing precision and attention to detail applies creative thinking and a collaborative high quality approach that ensures data integrity regulatory compliance and trust with cross functional partners and health authorities.

• • Lead development of Global CMC regulatory strategies across the product lifecycle.
  • Define prioritize and execute multiple CMC regulatory activities recognizing when to escalate decisions risks or strategic inflection points to management to ensure alignment and avoid placing CMC on the critical path for approvals.
  • Track manage and coordinate multiple CMC regulatory project timelines aligning ongoing activities across crossfunctional teams to ensure timely delivery of submission documentation.
  • Review and approve change control documentation providing clear regulatory expectations feedback on supporting data and guidance on appropriate regulatory pathways or strategies.
  • Provide regulatory assessment and strategic guidance on CMC documentation for regulatory submissions including evaluation of development plans control strategies labeling content and Health Authority responses. Ensure submissions are complete consistent and aligned with Health Authority expectations while effectively navigating regulatory ambiguity.
  • Author review and maintain CMC CTD sections across the product lifecycle including INDs/IMPDs NDAs/MAAs/NDSs and DMF/ASMF/MF submissions amendments supplements variations and annual reports ensuring highquality consistent submissionready content delivered in accordance with established timelines.
  • Serve as the primary CMC regulatory liaison with Health Authorities for designated assets which involves guiding agency communications creating briefing documents handling information requests and ensuring alignment with management on strategic or highrisk issues before making commitments.
  • Builds trusted relationships and influences internal and external stakeholders across global cross-functional teams including supply chain manufacturing sites CMC technical QA and CMOs.
  • Maintain expertise in emerging and evolving CMC regulatory requirements and proactively deliver training and regulatory guidance to Regulatory Manufacturing and Quality groups on applicable topics.
  • Able to incorporate AIdriven tools into CMC regulatory activities ensuring traceability and independent verification of information.
  • Function as a regulatory CMC technical expert for cross-functional teams.
  • Resolve importation and customs matters for assigned assets supporting product supply and operational continuity.
  • Provide support for labeling activities.
  • Manage and/or support Establishment Registrations Drug Listings and CARES Act reporting.
  • Other duties as assigned.

  Minimum Job Requirements

  Qualifications

  • Bachelors degree in a scientific discipline. Advanced degree preferred. RAC a plus though not required.
  • A minimum of 5 years (Senior Manager) or 7 years (Associate Director) of Regulatory Affairs CMC experience in a strategic and operational role.
  • In-depth knowledge of global CMC regulatory requirements across the product lifecycle (development registration and post-approval).
  • Proven hands-on experience with global regulatory submissions (e.g. INDs/CTAs NDAs/BLAs/MAAs) and accountability for postapproval lifecycle management submissions.
  • Demonstrated ability to effectively communicate influence and negotiate CMC regulatory strategies while building alignment across management and cross-functional teams.
  • Prior experience interfacing with Health Authorities on CMC-related topics.
  • Proficiency with regulatory systems (e.g. Veeva Vault eCTD etc.).

  Competencies

  • Indepth knowledge of global regulatory CMC requirements for advanced therapies and/or biologics across the product lifecycle including development registration and postapproval change management.
  • Solid understanding of the downstream development and commercialization implications of regulatory CMC decisions enabling riskbased phaseappropriate regulatory strategies.
  • Strategic and hands on regulatory leader able to independently develop regulatory CMC approaches and proactively align with regulatory leadership and management obtaining agreement on strategy prior to communication or implementation with crossfunctional teams.
  • Established record of leading crossfunctional CMC teams coordinating complex activities within a matrixed environment and exercising full ownership for the writing quality and delivery of regulatory CMC submissions and responses to Health Authorities.
  • Demonstrated success engaging with Health Authorities on CMC-related topics.
  • Advanced scientific writing skills with a strong focus on compliance quality and data integrity ensuring the regulatory CMC submissions align with global regulatory requirements.
  • Excellent verbal communication skills with demonstrated ability to act as a regulatory CMC spokesperson and effectively communicate aligned regulatory CMC strategies and positions across working teams crossfunctional forums and senior leadership.
  • Proven capability to assess regulatory risk and make informed decisions independently with clear judgment on when to escalate complex or highrisk CMC issues.
  • Ability to mentor and develop others.
  • High level of proficiency in Microsoft Office (Word Excel PowerPoint) enabling development of highquality regulatory documents data summaries and executivelevel presentations with minimal supervision.

  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 $140000 - $200000. 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.

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