Regulatory Affairs Associate II

LanceSoft Inc

Princeton, NJ

Apply

JOB DETAILS

JOB TYPE

Full-time

SKILLS

Biotech and Pharmaceutical, Component Assembly, Computer Skills, Corporate Policies, Data Entry, Data Management, Document Management, Documentation Standards, English Language, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Policy Development, Problem Solving Skills, Procedure Development, Regulations, Regulatory Compliance, Regulatory Requirements, Technical Writing

LOCATION

Princeton, NJ

POSTED

30+ days ago

Regulatory Affairs Associate II Hybrid working once fully trained. More on site presence whilst training. Role Purpose: Regulatory contractor for data management including data entry, review and labeling revisions. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures that labeling is in compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of labeling components for regulatory dossiers. May review labeling, extract pertinent information, prepare information abstracts and executive summaries of material searched. Major Accountabilities: To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Applies company policies and procedures to resolve routine issues. Contacts are primarily with labeling team and other personnel in department or group. Works on problems of routine scope. Follows established policies and procedures. Normally receives detailed instructions on all work. Education & Qualifications: BS in science or relevant field. Pharmaceutical and Regulatory Experience a plus. Experience: Pharmaceutical and Regulatory Experience a plus. Competencies: Computer literacy required. Strong organizational skills required. Typical activities may include work at a computer, copying, scanning, filing and, dependent on the position, considerable time may be spent sitting, standing or walking. Light lifting (up to 10-15 lbs.) may be required from time to time, consistent with an office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Skills & Knowledge: Proficient in computer entry, Word, Excel, Powerpoint and internet use. Language: English

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Resume Resources

Free Resume Templates Free Resume Builder