Regulatory Affairs Specialist
Edison-New Brunswick Metro Area, NJ
Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA. Assures effective involvement with change control systems. Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.
Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.
Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
Fluency (oral and written) in English language is strongly recommended.
Potential to be able to mentor and train other contractors is desirable but not essential.
Be proficient in the use of databases and tools (Regulatory databases, Excel, Powerpoint, etc.).
Minimum of a bachelor s degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
An understanding of Regulatory CMC and eCTD content Modules 1-3 through technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) or direct Regulatory CMC experience is required.