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Sr. Associate, Regulatory Affairs

Job Summary
The RA personnel will be responsible for providing support with US regulatory compliance across the Granules USA and Granules Consumer Health clienteles. In addition, lead post-approval commitments/requirements for ANDA and monograph products. The person will work cross functional teams to establish strategy, structure, communicate requirements and approve labeling documents within the organization for ANDA and monograph pharmaceutical products. Proactively review new regulations or GMP updates and develop/update SOPs or work instructions as needed. Responsible for supporting the company’s short- and long-term goals for maintaining compliance with applicable Regulations and cGMP Guidance Documents.

Principle Accountabilities
·      Subject matter expert (SME) for global labeling requirements for OTC and ANDA Products marketed by Granules USA.
·      Establish labeling strategy and requirements for customer labels and serves as the primary contact for customer label related requests.
·      Responsible for Drug listing of Granules USA marketed products. 
·      Review and approves product labeling and maintain labeling database.
·      Assists in leading regulatory training on labeling requirements including advertising promotional material.
·      Approves labeling to ensure compliance with corporate, regulatory, safety and legal requirements.
·      Initiates change control to ensure regulatory assessment are identified, documented and implemented.
·      Responsible for coordinating regulatory submissions for ANDA products to be packaged at contract packagers.
·      Reviewing and approving artwork files on various customer artwork portals (i.e., CVS, Walmart, Rite Aid, Walgreens, etc.…)
·      Providing support to QA as needed
·      Other assigned tasks by manager
·      Serves as a back-up to the supervisor as needed.
·      Prepare and maintain the internal Regulatory Databases. 
Reports to
Associate Director, QA
Knowledge & Skills
 MUST HAVE PRIOR EXPERIENCE in Drug listing, Labelling requirements, claim substantiation and QA support

  • Basic knowledge of drug safety and FDA regulatory requirements.
  • At least 2 years Experience in pharmaceutical drug safety.
  • Ability to work independently and collaboratively in a multidisciplinary team.
  • Excellent oral and written communication skills.
  • Computer proficiency (Microsoft Office and Adobe).
  • Flexibility to work outside of normal working hours.
Knowledge & Skills
·      Expert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc...)
·      Knowledge post approval regulatory submission requirements
·      Able to manage various projects and employees to meet submission deadlines
·      Strong analytical, organization, technical writing, and communication skills
·      Responsible to mentor and assist in the development of RA staff
·      Must have the ability to multi-task
·      Strong computer skills and working knowledge of Microsoft Office Suite, eCTD, and Adobe
  • Demonstrated ability to work on complex assignments in collaboration with various departments.