Regulatory Affairs Specialist

  • location: Groton, CT
  • type: Contract
  • salary: $65.47 - $77.02 per hour
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job description

Regulatory Affairs Specialist

job summary:
  • Collaborates with departmental and cross-functional colleagues (eg. G-CMC, WSR, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing life-cycle.
 
location: Groton, Connecticut
job type: Contract
salary: $65.47 - 77.02 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.
  • Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.
  • Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.
  • Leveraging both technical & regulatory knowledge, to mitigate risks.
  • Delivery of high quality regulatory submissions.
  • Execution of regulatory policies and operational processes.
  • Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
  • Execution and implementation of policies and operational processes.
  • Developing effective relationships with local & global internal partners, i.e., R&D (PTx, BTx, PCH), PGS, WSR, BU's, etc.,
  • Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Manage and Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Demonstrating ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • Execute training related activities (e.g. compliance-related, HR policies...), demonstrate & model adherence to all company behaviors & values, embrace & comply with GCMC Principles of Integrity.
  • Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
  • Managing contractors within a GCMC function, only if the position requires supervision of personnel.
  • Managing a small group of contractors within a GCMC function, conduct performance-management & training related activities, support roll-out of HR policies, assist recruitment & hiring vacancies, demonstrate & model adherence to all company behaviors & values, embrace & comply with GCMC Principles of Integrity.
  • Providing guidance & direction for direct reports, managing global resources & resource capacity along with prioritizing workload appropriately.
  • Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Developing relationships with regulatory authorities to improve the company's regulatory success
  • Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

    Organizational relationships include:

    - PGS functional leaders & site leaders

    - R&D (PTx, BTx, PCH) functional leaders & managers

    - WSR functional & regional leaders & managers

    - CMC Product & Regional Strategists

    - Regulatory authority reviewers, administrators &/or inspectors.

    - External partners, CMOs, CROs, consultant & contracted resources.
 
qualifications:
  • Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
  • Technical discipline with 8+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience
  • Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
  • Experience operating within GMP, GLP, or GCP related SOPs
  • Product release system exposure helpful
  • Managing contractors within a GCMC function, only if the position requires supervision of personnel.
  • 3+ years management & supervisory experience with technical projects &/or staff
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
  • Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.
  • Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
  • Strong understanding of CMC change management processes and CMC CTD content/structure.
  • Understanding of identifying and mitigating compliance risks through proper management of CMC product content
  • Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP's required to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or project(s).
  • Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.
  • Possesses sound understanding of business expectations across divisions
  • Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for assigned projects, mentor and share experience with colleagues.
  • An understanding of regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.
  • Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.
  • May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains
  • Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing discipline and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
  • May participate in limited interactions with regulatory authorities to respond to direct requests either directly or in conjunction with Regulatory Affairs.
  • Advanced skills in written & oral communications are mandatory.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
  • Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools
  • Experience engaging in the external regulatory & pharmaceutical environment is preferred.
  • Prior experience managing projects is preferred.
  • Lean and/or SixSigma experience helpful.
 
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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