About Our Parent Company Rubicon Research
Rubicon Research is an IP led, specialty pharmaceutical company focused on a mission to provide
innovative yet affordable patient-centered products and solutions to address unmet needs around the world. We leverage our proprietary technologies and specialized formulation development skills to provide solutions to complex delivery challenges, enabling better patient outcomes.
For more information visit
Advagen Pharma (Generics)
Incorporated in 2017 and operationalized in 2020, AdvaGen Pharma is an integrated specialty
pharmaceutical company, focused on providing innovative solutions for patients, customers, and partners
by developing, manufacturing, and marketing high quality prescription branded and generic
pharmaceutical products.
Job Description
Purpose This position will be responsible for regulatory communications for filings in US, managing meetings with USFDA, preparing regulatory strategies for global regulatory filings, regulatory assessments of MLR assets and filings, REMS activities and coordination, regulatory submissions for specialty/505b2 projects and co-ordination with global regulatory teams.
Position / Job Title : Manager/Sr. Manager
Department: Regulatory Affairs
Reporting To: Director – Regulatory & IP
Location: New Jersey
Years of Experience: 10-15 years
Job Responsibilities / Deliverables
• Manage regulatory communications for US filings.
• Manage meetings and discussions with USFDA.
• Prepare regulatory strategies for global regulatory filings.
• Responsible for regulatory assessments of MLR assets and filings.
• Coordinate on REMS activities.
• Coordinate with global regulatory teams.
• Manage regulatory submissions for specialty/505b2 projects.
• Ensure business growth and operational excellence within regulatory set up.
Qualifications & Pre-Requisites
• B.S/M.S in Pharmaceutical Sciences
• Proficiency in Regulatory Affairs.
• Knowledge about Pharmaceutical Product Development.
• Excellent communication, planning, analytical and interpersonal skills.
• Prior work experience with USFDA is preferred.
• Prior experience on specialty/505b2 projects is preferred
...Insight Global is currently hiring a Funds Disbursement Specialist for a large insurance client in the Austin, TX area. This role will require working fully onsite Monday through Friday during standard work hours. It will start as a 6 month contract-to-hire and will have...
Job Purpose Honda Aero, in Burlington, North Carolina, is looking for a team member who is a Fabricator with GTAW experience responsible for the fabrication and welding of aerospace sheet metal and casting engine components. Possesses the welding ability to certify to...
...Starting Sept 29th for a 3-month duration 120-bed LTC facility Travel offered, pending location | LTC experience preferred... ...qualifying placements Weekdays preferred Clinical duties only Dietitians On Demand is looking for a dietitian to join our team in the...
...requirements and performs essential functions. Completes all mandatory training as required. Performs other duties as assigned. 2. Quality... ...Physical Requirements Indoor, temperature controlled, smoke free environment. Exposure or potential exposure to blood and...
...About the Company Management Support Solutions, LLC (MSS) has been engaged to find a Commercial HVAC/R Service Manager for Miami FL. Silver State Refrigeration & HVAC specializes in providing aftermarket commercial HVAC, refrigeration, and plumbing maintenance and repair...