Senior Regulatory Affairs Specialist

04 Aug, 2022

Jobs

Senior Regulatory Affairs Specialist

Septodont
Lancaster, PA

Job Title

Senior Regulatory Affairs Specialist

Company Details

Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 1,800 people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations has facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

Job Summary

 

The Senior Regulatory Affairs Specialist is accountable to the Regulatory Affairs Manager for all areas relating to supporting the regulatory activities of Septodont. In respect to the pharmaceutical product and medical device registrations, both current, and future, in the Canadian, and US marketplace, including direct involvement with Septodont (France) and Novocol (Cambridge).  This position seeks to ensure that all corporate and governmental regulations and procedures are upheld.

 

Responsibilities

 

  • Assumes all U.S. Agent responsibilities from communicating with FDA on drug/device product follow up/issues, generation of cover letters/forms for post marketing submissions/deficiency responses and representation/preparation during Pre-IND meetings
  • Maintaining and managing the FURLS/DFUF systems for devices and the GenNext portal for drugs
  • Represents regulatory concerns and interests on assigned project teams and in inter-departmental meetings
  • Leads and/or manages projects as needed to compile documentation and prepare packages necessary for regulatory submission approvals such as ANDA/NDA or 510(k)s
  • Communicates with other departmental managers and relevant personnel in preparation of studies, documents, or any tasks related to complying with regulatory requirements and filings
  • Routinely interacts with government regulatory bodies such as FDA, related to filing product submissions and updates, and follows up in a timely manner to negotiate timely approvals
  • Ensures documentation packages are in compliance with regulatory requirements including giving support to all eCTD/CTD and 510(k) construction.  Leads the process of preparing necessary documents and responsible for thorough review of documents to ensure regulatory compliance
  • Ensures proper storage and control of all regulatory related documentation, including keeping on file relevant correspondence for reference and follow-up
  • Conducts other related regulatory affairs activities consistent with the role of a Senior Regulatory Affairs Specialist
  • Obtains, prepares and reviews documentation required for related filings (including routine annual updates for drug products and Letters to File for device products)
  • Monitors published scientific literature pertinent to the dental anaesthetic/device usage and experience
  • Maintains the corporate Regulatory Database and Change control – RDB
  • Reviews/approves/submits advertising for drug/device product in the US
  • Supports sales and marketing directives and client requests
  • Supports Quality Assurance during FDA auditing, recalls or incident investigation
  • Performs other related duties as required
  • All GMPs, SOPs and company policies must be followed
  • Observes and support all safety guidelines and regulations
  • Must follow safety rules/regulations and report any workplace injuries or accidents to manager immediately
  • Works harmoniously with all fellow employees

 

 

Qualifications

 

Education 

  • University science degree or equivalent – e.g. 3-year community college or degree in Life Sciences (years of experience would be taken into consideration)
  • Certification /designation within the RA field would be an asset

Experience

  • Minimum five (5) years of experience in a regulated industry such as pharmaceutical and/or medical devices, including five (5) years in a direct regulatory capacity
  • Experience creating/filing eCTD/CTD and 510(k)s for the US with successful approvals

 

 

Contract type

Permanent

Candidate criteria

Minimum level of education required

2- College

Minimum level of experience required

2-5 years

Learn more here

Job posted: 2022-08-04