Sr Regulatory Affairs Associate

Summary

Coordinate the necessary activities directed toward generating the required elements for FDA drug product regulatory submissions to FDA.  Coordinate activities leading up to the generation of information requested by the FDA, through the regulatory review process of drug product applications.  Coordinate submission preparation with departments which supply submission documentation.  Represent the Regulatory Affairs department in cross-functional initiatives, as necessary.

Essential Duties and Responsibilities

• Regulatory Submission and Support
• Review and approve (as required) regulatory submission documents for regulatory acceptability.
• Compile all the necessary documentation for chemistry, manufacturing, and controls submissions (CMC) to the FDA.
• Prepare CMC data sections for new product applications, amendments and supplemental submissions.
•  Coordinate activities leading to responses to FDA deficiency letters and information requests for regulatory submissions.
• Assist marketed product support by providing insight into drug product approval conditions for post-approval activities. 
• Serve as regulatory representative on new product and/or marketed product support cross-functional teams through the development lifecycle of submitted products.
• Assist in change control review on routine items for regulatory impact under supervision.
• Interact with Regulatory agencies for routine items.
• Assist Regulatory management is the creation of project timelines for one or more projects.
• Maintain tracking documents for submissions and follows-up with internal and external clients.
• Assist Regulatory management in working with outside vendors and/or Zydus India on the preparation of the clinical sections of original drug product applications and supplemental submissions.
• Assist in activities leading to responses to FDA deficiency letters and information requests for regulatory submissions.
• Assist in the preparation of regulatory assessments of key issues with potential for regulatory application actions.
• Regulatory Operations (Electronic Publishing (ePublishing), Adverse Events, Labeling)
• Prepare product submissions in the electronic publishing system or work with external ePublishing vendors to complete electronic publishing of product applications.
• Define and communicate electronic submission requirements (FDA/ICH).
• Ensure electronic submissions are complete and in accordance with FDA/ICH guidelines.
• Assist in the development and maintenance of submission standards.
• Assist in the adverse event processing system and the submission of adverse event reports to regulatory authorities.
• Create, review, and approve product labeling to identify appropriate content and format of required product information.
• Review and approve all revisions to approved drug product labeling. 
• Review and approves clinical trial and development batch labeling for accuracy and required information.

General

         Assist in archiving and maintenance of product submissions and FDA correspondence, including but not limited to, submissions documents, adverse event correspondence and departmental labeling review files, per applicable departmental/company SOPs.

• Take management direction, but able to identify project needs proactively.
• Take on assignments with increasing complexity.
• Assist in the development of departmental SOPs, as required.
• Serve as Regulatory Representative to project teams.
• Provide support during FDA pre-approval inspections, as necessary.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Knowledge of and ability to apply regulatory regulations.
• Leadership skills to coordinate and provide guidance to all levels of personnel.
• Excellent writing skills.
• PC proficiency using Microsoft Office suite.
• Project management skills.
• Excellent communication skills and ability to effectively interact with many departments.
• Flexible, with ability to handle and coordinate multiple projects in a dynamic, fast-paced environment.

EDUCATION/EXPERIENCE

• Bachelor's degree in the sciences preferred or equivalent combination of Bachelor's degree and pertinent experience in pharmaceutical or other highly regulated industry.
• Minimum eight years' experience in the pharmaceutical industry.
• Minimum five years' actual regulatory experience with relevant dosage form products.
• Comprehensive knowledge and experience in the application of FDA regulations and guidelines as they pertain to product development and submissions.
• Prior experience in dealing with regulatory agencies preferred.
• Experience with CTD format highly desired.
• Experience with electronic submissions and/or content management systems highly desired.
• Regulatory Affairs Certification (RAC) desired.

Work Environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

Stand, walk, sit, reach, talk, and hear.

1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
2. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Normal office conditions.
2. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Sr Regulatory Affairs Associate Jobs at Nesher Pharmaceuticals (USA) LLC