Regulatory Affairs Specialist

3 weeks ago

Bangor, United States Biospectra, Inc. Full time

 

Exciting career opportunity alert Join our team at BioSpectra, where we support the top 25 pharmaceutical companies globally. We are looking for an experienced Regulatory Affairs Specialist to contribute to our success.   

As a Regulatory Affairs Specialist, you will play a crucial role in connecting companies, their products, and regulatory authorities. The ideal candidate will bring excellent communication, analytical, and project management skills to handle complex information, engage with diverse stakeholders, and juggle multiple deadlines.  Moreover, attention to detail, problem-solving skills, and ethical awareness are crucial in maintaining accuracy, compliance, and integrity to BioSpectra’s rigorous quality standards. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API’s, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA, and Scarborough, Canada.  Why should you join BioSpectra, Inc.?  

  • Support our current customers who are the top 25 pharmaceutical companies in the world
  • Develop your career with a growing organization with ample opportunities for professional and personal development
  • Comprehensive Benefits Package (Medical, Dental, Vision, Company paid Life Insurance, Tuition Reimbursement)
  • 401K Retirement Savings Plan – Company matches $2 per $1 of employee contribution on the first 4%  
  • Excellent Paid Time Off Programs include vacation, sick, & personal time, plus paid holidays

Job Summary: The Regulatory Affairs Specialist is directly responsible for the preparation, organization, compilation, and ongoing maintenance of the regulatory dossiers.  This position is responsible for the maintenance of Chemistry, Manufacturing and Control sections of regulatory submissions to global and domestic regulatory agencies including tracking of internal documentation to ensure submissions remain current. Essential Duties and Responsibilities: 

  • Maintains an understanding of current federal, state, local and/or company regulations applicable to BioSpectra and BioSpectra products.
  • Specializes in the compilation of Modules 1, 2 and 3 of the eCTD filings for Drug Substances and Excipients.
  • Ensures all drug master files, veterinary master files, active substance master files, and CEPs are current and compliant with regulatory agency requirements.
  • Ensures all BioSpectra Change Controls are included in Regulatory Submissions in a timely manner. 
  • Files and Archives Regulatory Documents as required.
  • Reviews data and establishes conclusions based on the evaluation of data to support regulatory filings.
  • Remains current with new regulations and regulatory changes and provides the regulatory team with applicable information.
  • Provides regulatory information, guides and summarizes the impact to the quality system to applicable departments, as appropriate.
  • Provides support documents for drug substance listing for filing to the US FDA or other global regulatory agencies as required by management.
  • Ensures Good Documentation Practices are followed on all regulatory submitted documentation.
  • Responsible for preparing all regulatory documents as assigned by management.
  • Assists in regulatory inspections including any necessary responses and CAPA plans. 
  • Ensures Regulatory Requirements in Customer Quality Agreements are maintained in a compliance. 
  • Completes required regulatory and compliance documentation requests to support product commercialization.
  • Assists with the development and evolution of the Regulatory Program procedures and policies.

Qualifications: 

  •  Four-year degree in Science or related field
  • 4 year minimum experience working in a cGMP environment ideally Active Pharmaceutical Ingredient related
  • Has a working knowledge and understanding of ICH Q7, 21 CFR 210 and 211, Part 11 and Annex 11
  • Knowledge of Global Regulatory Affairs including but not limited to United States, European, Canada, and Asia 
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Experience with relevant software applications including MS Office, Excel, Minitab and Adobe
  • Ability to communicate effectively with staff, management, customers and/or regulatory agencies
  • Ability to handle sensitive information in a confidential manner
  • Close vision, distance vision, ability to adjust focus, ability to distinguish color change, and the ability to use a computer for extended periods of time.

 Work Hours: 

  • Exempt Position
  • Minimum of 40-45 Hours Week, or other agreed upon documented schedule
  • Ability and willingness to work from all BioSpectra facilities

Ready to make a difference in the biopharma industry? Apply now and be part of a talented team driving excellence at BioSpectra #biospectracareers #LI-BM1

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