Sr. Regulatory Affairs Product Specialist

Company DescriptionEstablished in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service OfferingsWe offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to:- Temporary Staffing- Permanent Staffing- Payrolling- Recruitment Process Outsourcing (RPO)- Back-office Services- Application Design and Development- Website Design and Development- Program/Project ManagementOur Domain StrengthWith currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic CoverageLanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients.Awards and AccoladesFollowing are some of our awards and accolades in the US Contingent Workforce space:- Manpower “Premier Vendor” – 2014- Kelly’s “Supplier Innovation Award” – 2012- Kelly’s “Supplier of the Year” Award – 2012 and 2011- Kelly’s “Service Excellence Award” – 2010 and 2009- “Stewardship Recognition” from Johnson & Johnson’s (J&J) Kelly Work sense programSpecialtiesIT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and DevelopmentJob DescriptionSummary of position: · The Sr. Regulatory Affairs Product Specialist is responsible for developing and implementing regulatory strategies for assigned drug products throughout the product lifecycle in the Specialty Generics business of Client’s. This position will help lead regulatory efforts to obtain approvals in order to market new generic drug products and provide ongoing regulatory support for all post-marketed projects and programs, ensuring maintenance and regulatory compliance of marketed generic drugs. Essential functions: · Serve as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization. · Perform regulatory assessment on all proposed change control; gather required data as needed to defend a Regulatory filing strategy; coordinate and prepare post-approval supplements if warranted. · Manage, prepare, publish using eCTD software well-organized, scientifically sound CMC and safety-related regulatory submissions which include ANDAs, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format. · Coordinate and communicate timelines and deliverables with Regulatory Operations, Labeling and other key departments to facilitate quality CMC and safety-related regulatory submissions, including ANDAs, Amendments, Annual reports, PSUR and post approval Supplements. · Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments. · Work with partners to create product labeling compliant with FDA, and compendial requirements for drug products. · Contact FDA and other Regulatory authorities for review status updates for pending applications and supplements. Education required: · Bachelor’s degree required in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Graduate degree preferred. Experience: · Minimum 5 years of experience in the Pharmaceutical Industry. · Knowledge/Skills/Qualifications: · Hands on experience in leading a variety of Regulatory submission activities (ANDAs, Post Approval Supplements, PSURs, Annual Reports.) · Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department. · Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate throughout the product life-cycle. · Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data. · Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. · Familiarity with Trackwise · Ability to manage a variety of assignments. · Detail oriented and highly organized. · Strong interpersonal skills and ability to deal effectively with a variety of personnel including senior managementAdditional InformationThanks and RegardsDishant Nagar 703-480-4117SummaryType: Full-timeFunction: Quality AssuranceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals