Regulatory Affairs Associate Job at Garonit Pharmaceutical, Fairfield, Essex County, NJ

TXRqaWdadVlwQlFPcTR4Z2ExN2J1bGhHTkE9PQ==
  • Garonit Pharmaceutical
  • Fairfield, Essex County, NJ

Job Description

Regulatory Affairs Associate

Summary

This position is full-time located in the Fairfield, NJ office. Some travel will be required. The job involves all aspects of Regulatory Affairs for Pharmaceutical API’s and Finished Dosage. This position is focused on the USA with our ANDA and NDA filings but will also have responsibility for Europe and Japan. This position reports to the President and work closely with corporate leadership.

Responsibilities

  • Manage and monitor preparation, submission and review of regulatory documentation in collaboration with all regulatory filings (DMF/ANDA/NDAs/PDMA/CEP). 
  • Act as an in-house regulatory expert, advising and supporting, all countries associated with Garonit Pharmaceuticals (NA, Europe, and Japan)
  • Lead the implementation of global regulatory strategies taking into consideration the overall development program objectives.
  • Provide regulatory support to our global customers. Proactive leadership that supports our customers.
  • Monitor process for new product development
  • Plan and review all Finished Dosage Filings
  • Involved in procurement of ANDA/NDA’s

Qualifications

  • Must have experience in preparing and filling ANDA, NDA application with US FDA
  • Strong working experience with a variety of regulatory authorities is required, with real firsthand experience of managing registrations with different regulatory authorities
  • Experience in leading and managing complex/virtual networks suppliers and partners to deliver and maintain regulatory approvals is essential
  • Proven track record in influencing and shaping optimal regulatory outcomes
  • Experience with FDA and other regulatory authorities
  • Proven ability to work effectively in a team environment
  • Professional experience as part of a regulatory agency would be useful

 

Education & Experience

  • Bachelor’s degree in science (Master’s in discipline would be preferred).
  • Minimum 3-5 years’ regulatory experience in the pharmaceutical industry

 

Benefits

· Health Insurance

· Dental Insurance

· Vision Insurance

· 401K

· Paid time off

Job Tags

Full time, Work experience placement, Work at office,

Similar Jobs

CMD CORPORATION

Model Maker Job at CMD CORPORATION

 ...Job Description Job Description Position: Model Maker Reports to: Director of Automation & Technology Solutions Supervisory Responsibilities: None Our Purpose: Making It Better Together We believe in building lifelong partnerships, providing high performing... 

Providence Health and Services

RN - Wound Ostomy Job at Providence Health and Services

 ...Description RN Wound Ostomy at Providence Newberg Medical Center. This posting represents a 0.8 FTE, day shift opening (8am...  ...You will thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice... 

Kane Transport

CDL-A Local Fuel Tanker Truck Driver Job at Kane Transport

*CDL-A Fuel Tanker Job Opportunity* Local Truck Driver - PM Shift - Grand Rapids, MN *Rewarding Career Starts Here!** Load pay * $1,600-$2,250 Weekly gross earnings * *Free paid BCBS medical insurance plan for family (for PM positions only) savings of $7,00... 

Ground Up Careers

Construction Superintendent Job at Ground Up Careers

 ...Opportunities for professional development and training. Friendly and collaborative work environment. About the Role As a Construction Superintendent, you will oversee all phases of construction projects, from planning to completion. Youll be responsible for delivering... 

Allied Universal

Posting Security Professional - School Site - Part Time Job at Allied Universal

 ...Security Professional - School Site - Part Time Allied Universal, North Americas leading security and facility services company, provides rewarding careers that give you a sense of purpose. While working in a dynamic, diverse, and inclusive workplace, you will be part...