Senior Regulatory Affairs Specialist sought by Syner-G Pharma LLC in Southborough, MA to provide regulatory consulting and contract services to clients in the areas of Chemistry, Manufacturing, and Controls, to ensure compliance with FDA, EMA, and global regulatory requirements.
Job Description and Job Duties
Provides regulatory consulting and contract services to Syner-G’s clients in the areas of CMC (Chemistry, and Manufacturing and Controls) regulatory affairs to ensure compliance with FDA, EMA and global regulatory requirements; assures the quality of the investigational and commercial drug substances and drug products; assesses current registered content, proposed changes, and justification for changes by utilizing TrackWise during pre-submission planning strategies; authors, reviews, and finalizes submission detailing changes and impacts on the approved drug products and categorizes the changes based on risks of impact, through RCAM (Regulatory Content Authoring and Management); communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review; reviews pending submissions through ORION (One Regulatory Information Online Network) and generates Cognos ORION reports for status updates on filings submitted to Health Authority; coordinates and documents internal regulatory processes, such as internal audits, inspections, license renewals, or registrations; tracks submission schedules and timelines through Excel and Appian; and submits documents to publishing team for country release and archival to Radr.
Must have a Master’s Degree in Chemistry or Biochemistry. Must have three (3) months of experience in the job offered or as a Regulatory Affairs Specialist.
Three (3) months of experience must have included all of the following:
1) CMC, RCAM, TrackWise
2) ORION, Cognos; and
Must have relevant education and experience. Send 2 resumes & cover letter (no calls) to 2 Park Central Drive, Ste 110, Southborough, MA. REF#8478.023