Sr. Regulatory Affairs Product Specialist

Location: Hazelwood

Company Description Established in 2000, A Minority Business Enterprise (MBE), Lance Soft 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 Offerings We 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 Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, Lance Soft 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 Coverage Lance Soft  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 Accolades Following 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 program

SpecialtiesIT/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 Development

Job Description Summary 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…