Global Regulatory CMC Manager

Job Description

Job Summary:

• The Client organization provides regulatory expertise related to  activities through all stages of a product’s lifecycle.
• Members of the organization develop global regulatory  strategies and partner with key stakeholders to execute the strategies in alignment with business priorities.
• The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions.
• The team also supports Medical Information to build/maintain databases to address external questions regarding drug products.
• The Client Manager is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding.
• Clinical trial applications; New marketing applications; HA responses and background packages (including participating / leading HA meetings with support); and/or post-approval submissions. In this role, the Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (Client), Global Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO).
• The Client-Senior Manager II will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Duties & Responsibilities:

• Support project teams (e.g. TPT /  , GRT, TTT, MLT, GO Team, etc.) for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions.
• Provide strategic  regulatory expertise for development project teams.
• Provide strategic input to development and GO teams to mitigate drug supply issues.
• Interpret global regulations and guidance.
• Identify, communicate and propose resolution to routine issues.
• Participate in product fact finding meetings with supervision.
• Interface with the Health Authorities for submissions and  -related issues, with guidance and oversite from supervisor on complex topics.
• Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success.
• Provide technical teams insight into regulatory health authority expectations.
• Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success.
• Ensures the necessary updates are provided to team leaders , (GRL, Line manager etc.)
• Support the preparation of  policies and procedures.
• Utilize electronic systems for dossier creation and tracking.

Required Qualifications:

• Minimum BA/BS Degree.
• 4-6+ years pharmaceutical or related experience (min BA/BS).
• 4+ years of  regulatory or related experience.
• Knowledge of Client regulatory requirements for advanced therapies and/or small molecules, biologics, cell therapy during development and post-approval as applicable.
• Knowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicable.
• Demonstrated ability to develop/maintain strong working relationships cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
• Ability to identify, communicate and resolve routine/complex issues.
• Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
• Ability to interpret global regulations and guidance documents.
• Demonstrated ability to be solution-oriented.
• Seeks multiple perspectives and listens openly to others’ points of views.
• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Search for opportunities for continuous improvement.
• Strong oral and written skills.
• Proficient with electronic systems.
• This position may require up to 5% of travel.