Rahway Rahway, NJ 07065
Job Title: CMC 2
Location: Rahway, NJ - 07065
Duration: 6 Months+
About Our Client: Client is a global professional services firm that makes business transformation real. We drive digital-led innovation and digitally-enabled intelligent operations for our clients, guided by our experience running thousands of processes primarily for Global Fortune 500 companies. we have expanded from 19,000+ employees and annual revenues of US$491.90 million to 80,000+ employees and annual revenues of US$3.00 billion as of December 31, 2018.
- Essential function(s) includes, but is not limited to:
- Reporting to the Associate Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.
- The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
- Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Liaise with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle
- Identify and communicate potential regulatory issues to GRACS CMC, as needed
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Demonstrated effective leadership, communication, and interpersonal skills.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities.
Yamini: firstname.lastname@example.org - 678-203-2377