Senior Drug Safety Regulatory Analyst ( US,EU Market )

About Infodesk www.infodesk.com

Infodesk is the leading enterprise intelligence management SaaS platform, serving the top 100 companies acrossglobal 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 Drug Safety Regulatory Analyst to provideand 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 i ntern al stake holders establishand enforce scope of work and enable InfoDesk’s teams to fulfill services according to scope.
• Research publiclyavailable websites from Regulatory Authorities and other relevant websites to identify and manage the information strategy process.
• Create searchesand 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 impacton company and client activities.
• Identify and interpret relevantregulatory guidelines, as they relate to Infodeskclient projects
• Advise others on regulatory and compliance matters,as they relate to Infodeskclient projects.
• Explain regulations, policies, or procedures, as they relate to Infodesk stakeholders.
• Coordinate regulatory documentation activities, in accordance to client projectscopes
• Provide technical review of data or reports.
• 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

• 15 plus years in the Pharmaceutical Industry or regulatory strategy or similartraining / experience

• Strong knowledgeof current North America and EU regulations, and familiarity with international regulations.

• 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 of INDs/IDEs/BLAs/NDAs/510(k)s/PMAs, marketing applications and other regulatory submissions and pathways (orphan drug, PRIME, IRP etc).
• Experience with drug safety regulation, drug safety monitoring or pharmacovigilance preferred.
• Ability to manage complexprojects and timelinesin a multinational/multicultural team environment.

Preferred Skills:

• Regulatory Affairs Certification.
• Past experience includes any of the following: review of product promotional materials, labeling (including changemonitoring), batch records,specification sheets, or test methods for compliance with applicable regulations and policies.
• Knowledge and experience in drugs, biologics, devices or combination products.