LevittownPARecruiter Since 2001
the smart solution for Levittown jobs

Regulatory Affairs Associate

Company: Torrent Pharma Inc.
Location: Levittown
Posted on: March 22, 2020

Job Description:

Responsible for assisting the Regulatory Team with the preparation of all regulatory submissions including ANDA, amendments, annual reports and safety reports. -The individual will maintain the relevant documentation generated for these filings. Location Basking Ridge ,New Jersey OR Levittown,PA Responsibilities: Provide regulatory support to all functional groups. Create, organize and coordinate the preparation of FDA submissions including ANDAs post approval changes and PLAIRs (Pre-Launch Activities Importation Requests). Participate in the preparation and submission of the requisite Annual Reports, and PADERs (Periodic Adverse Drug Experience Reports) for approved ANDA's. Respond to deficiencies received from FDA. Assist with Pharmacovigilance, Product Complaints and Medical Information function for the U.S. Generics business. Responsible for data entry, filing, archiving, and maintenance of submission trackings. Foster collaborative, efficient and effective working relationships with internal team in India and the US. Monitor and communicate new regulatory requirements and/or review trends to affected functional areas such as R&D, Quality, Operations, Sales and Marketing. Additional responsibilities may be assigned as appropriate. Desired Skills: Experience in submission of ANDAs and supplements; maintaining approved ANDAs in compliance with guidance to research and operations professional staff. Understanding of ICH and FDA guidelines Understanding of R&D processes required for ANDA submissions. Requirements: Minimum B.S. in scientific discipline, M.S. preferred. At least 5 years of experience in the pharmaceutical industry including 3 plus years regulatory affairs experience in both pre and post approval pharmaceutical FDA submissions. Knowledge of filing and approval process for generic drug products. Experience in dealing with the FDA - OGD is desirable. Experience writing and assembling the supporting documentation for ANDAs and other regulatory filings, including familiarity with CTD format and eCTD submissions. Knowledge of product development milestones and compliance requirements. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data. High degree of motivation and initiative are required. Proven ability to anticipate challenges and negotiate through them to achieve desired outcome. Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents. Excellent communication, verbal and written English skills and ability to/experience of work across cultures and time zones. Ability to work successfully within a team/collaborative environment with a high level of professionalism and with the parent company personnel in India. Proficient with Adobe, eCTD software and Microsoft Office applications.

Keywords: Torrent Pharma Inc., Levittown , Regulatory Affairs Associate, Other , Levittown, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Amazon Warehouser - Earn $15 or more
Description: Warehouse/Shopper Team Member Seasonal, Part-Time, Full-Time, Flexible Hours br br Shifts: br Overnight, Sunrise, Day, Evening, Weekend br br Location br Manhattan, The Bronx, Brooklyn (more...)
Company: Amazon
Location: Bayonne
Posted on: 03/31/2020

Warehouser - Earn $15 or more
Description: Warehouse/Shopper Team Member Seasonal, Part-Time, Full-Time, Flexible Hours br br Shifts: br Overnight, Sunrise, Day, Evening, Weekend br br Location br Manhattan, The Bronx, Brooklyn (more...)
Company: Amazon
Location: Hoboken
Posted on: 03/31/2020

Picker/Packer
Description: Warehouse Team Member Seasonal, Part-Time br br Shifts: br Overnight, Sunrise, Day, Evening, Weekend br br Location br 18 Applegate, Dr. Robbinsville,
Company: Amazon Workforce Staffing
Location: New Brunswick
Posted on: 03/31/2020


Registered Nurse RN
Description: DaVita is seeking a Registered Nurse who is looking to give life to patients in an Acute Hospital setting. RNs in this role work autonomously alongside the hospital staff to assess, troubleshoot, and (more...)
Company: DaVita
Location: Lancaster
Posted on: 03/31/2020

Picker/Packer
Description: Job DescriptionWarehouse Team Member Seasonal, Part-Time Shifts: Overnight, Sunrise, Day, Evening, Weekend Location 18 Applegate, Dr.
Company: Amazon Workforce Staffing
Location: New Brunswick
Posted on: 03/31/2020

Computerized System Validation
Description: Description Despite current events, one of the leading generics and specialty pharmaceutical companies in the country located in NJ is looking to hire several recent college graduates to join their Computer (more...)
Company: Robert Half
Location: New Brunswick
Posted on: 03/31/2020

MC Tech & Digital Partner
Description: We have an exciting opportunity for a senior-level consulting professional to join our practice management team as a Tech Digital Management Consulting Partner. Our ideal candidate has a breadth of (more...)
Company: RSM International
Location: New Brunswick
Posted on: 03/31/2020

Sr. UI Designer
Description: Sr. Graphic / User Interface Designer Department: Marketing / Creative / Design Reports To: Art Director, WES -- -- We are in one of the most dynamic periods in our history as technology globalism and (more...)
Company: Wiley
Location: Hoboken
Posted on: 03/31/2020

Sr Outside Property Adjuster - New Jersey
Description: Wednesday, October 2, 2019 br br Our Outside Property claims department is seeking a Field Adjuster or Sr. Field Adjuster for the Northern NJ area. br br Position summary: br br Outside property (more...)
Company: The Hanover Insurance Group
Location: Hackensack
Posted on: 03/31/2020

Assistant Director Of Nursing RN
Description: 425 N Duke St, Lancaster, PA 17602, USA Shifts Available: Full time We are seeking a Assistant Director Of Nursing RN for our 124-bed skilled nursing facility Rose City Nursing and Rehabilitation
Company: Rose City Nursing and Rehab
Location: Lancaster
Posted on: 03/31/2020

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Levittown RSS job feeds