Senior Regulatory Delivery Analyst ( US,EU Market )

About Infodesk www.infodesk.com

Infodesk is the leading enterprise intelligence management SaaS platform, serving the top 100 companies across global life sciences, government, professional, and investment services. InfoDesk's proprietary "Smarter Data" technology gathers, normalizes, enriches, and summarizes content in real time from external and internal sources to deliver business-critical insights that help clients increase their competitive awareness, mitigate risks, and make confident data-driven strategic decisions.

InfoDesk is looking for a Senior Regulatory Delivery Analyst to provide and manage projects that meet the custom information needs of high-profile, clientele of global pharmaceutical and biotech companies. This is a unique role and to be successful, you will have a deep understanding of regulatory submissions and requirements or product development, including research, clinical trials, manufacturing practices, regulations and approvals processes.

Responsibilities:

• Ensure completion of regulatory projects for InfoDesk’s customers in line with customer scope Work directly with InfoDesk internal stake holders establish and enforce scope of work and enable InfoDesk’s teams to fulfill services according to scope
• Research publicly available websites from Regulatory Authorities and other relevant websites to identify and manage the information strategy process.
• Create searches and apply standard “search logic” (including Boolean) to find certain websites that provide information on applicable laws and regulations.
• Evaluate applicable laws and regulations to determine impact on company and client activities Identify and interpret relevant regulatory guidelines, as they relate to InfoDesk client projects Advise others on regulatory and compliance matters, as they relate to InfoDesk client projects Explain regulations, policies, or procedures, as they relate to Infodesk stakeholders
• Coordinate regulatory documentation activities, in accordance to client project scopes
• Provide technical review of data orreports
• Maintain data in information systems or databases
• Ability to navigate the Web and tools to consume content, like RSS, Google Alerts etc.

Must have:

• BA/BS in scientific/engineering/healthcare discipline, Masters, PharmD or Ph.D preferred
• 10-18 years in the Pharmaceutical Industry orregulatory strategy or similar training / experience Strong knowledge of current North America and EU regulations, and familiarity with internationalregulations.

• Knowledge of and broad experience with regulatory procedures and legislation for drug/device development (specifically GxPs), product registration, line extension and license maintenance (US, CA & EU required).

• Understanding of regulatory controls and marketing pathways INDs/IDEs/BLAs/NDAs/510(k)s/PMAs, marketing applications and other regulatory submissions and pathways (orphan drug, PRIME, IRP etc)
• Ability to manage complex projects and timelines in a multinational/multicultural team environment