Global Regulatory CMC Manager

Global Regulatory CMC Manager

Location: 50% onsite at Giralda Farms, NJ, 07940 Duration: 6 Months Hours: Mon-Fri 8am-5pm

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC 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 GRS-CMC 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 CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS), Global Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO). The GRS-CMC Senior Manager II will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Support project teams (e.g. TPT / CMC, 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 CMC 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 CMC submissions and CMC-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 (CMCL, GRL, Line manager etc.)

Support the preparation of CMC policies and procedures

Utilize electronic systems for dossier creation and tracking

Minimum BA/BS Degree

4-6+ years pharmaceutical or related experience (min BA/BS). 4+ years of CMC regulatory or related experience

Knowledge of CMC 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

The hourly rate for this position is between $98 and $100 per hour. Factors which may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate]. Benefits: Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations