Regulatory Affairs Specialist Job at Stark Pharma Solutions Inc, Franklin Lakes, NJ

UFpFTzhMZ2xSV1ZiZjhsOFFlR2NvQzBZ
  • Stark Pharma Solutions Inc
  • Franklin Lakes, NJ

Job Description

Job Title: Regulatory Affairs Specialist

Locations: New Jersey Pennsylvania Massachusetts Connecticut Rhode Island Salt Lake City (UT) California

Duration: Long Term contract

Job Summary

We are seeking experienced Regulatory Affairs professionals to support regulatory strategy submissions and compliance activities across pharmaceutical biotechnology and medical device programs. This role will work closely with cross-functional teams to ensure products meet global regulatory requirements throughout development approval and commercialization.

The ideal candidate will have strong experience with FDA regulations regulatory submissions and lifecycle management activities in regulated environments.

Key Responsibilities

  • Prepare review and support regulatory submissions including INDs NDAs BLAs 510(k)s PMAs amendments supplements and annual reports
  • Develop and execute regulatory strategies to support product development and commercialization
  • Ensure compliance with FDA EMA ICH and global regulatory requirements
  • Collaborate with Quality Clinical R&D Manufacturing and CMC teams on regulatory activities
  • Support change control assessments labeling updates and product lifecycle management
  • Review technical documentation SOPs and regulatory filings for accuracy and compliance
  • Support regulatory inspections audits and agency interactions
  • Monitor evolving regulatory requirements and communicate impact to internal stakeholders

Required Qualifications

  • Bachelors degree in Life Sciences Pharmacy Regulatory Affairs Engineering or related field
  • 3 10 years of experience in Regulatory Affairs within pharma biotech or medical devices
  • Strong knowledge of FDA regulations and global regulatory frameworks
  • Experience supporting regulatory submissions and compliance activities
  • Excellent communication technical writing and project management skills
  • Ability to work cross-functionally in fast-paced environments

Job Tags

Long term contract, Full time

Similar Jobs

Acara Solutions

Digital Marketing Specialist Job at Acara Solutions

 ...Acara Solutions is seeking a Digital Marketing Specialist to work with our client Headquartered in Boston, MA. This position is 100% remote. Pay:$25.00/hour Schedule: Full Time 40 Hours per week Job Type:6-month contract with possible opportunity of extension... 

Porter W Yett

Heavy Haul Truck Driver Job at Porter W Yett

 ...About the Role: The Heavy Haul Truck Driver plays a crucial role in the construction industry by transporting oversized and heavy loads to various job sites. This position requires a high level of skill and attention to detail to ensure that all loads are secured and... 

Confidential

Physical Therapist / Outpatient Rehab Job at Confidential

Title: CT Technologist / Radiology Location: Gratiot, OH Here's your opportunity to join one of the nation's top 100 hospitals recognized by Forbes, where career advancement and professional fulfillment await. Committed to exceeding patient expectations and fostering...

Blue Wave Travel

Virtual Travel Advisor Job at Blue Wave Travel

 ...We are looking for a Travel Advisor who is passionate about traveling. You will manage travel requirements made for business or holidays, and you will provide tourism-related...  ...* Sound knowledge of domestic and international travel trends * Degree in Hospitality, Travel... 

Midlands Contracting

Excavator Operator Job at Midlands Contracting

 ...We are currently seeking a skilled Excavator Operator to join our growing construction company. A strong work ethic, attention to detail, willingness to travel, and dependability are a must. Job Details ~$27 per hour and up depending on experience ~50 or more hours...