Regulatory Affairs Specialist

Why you should join BioSpectra?

• Direct Placement-Comprehensive Benefits Package (Health, Dental, Vision, & Life Insurance $50,000)
• 401K Retirement Savings Plan – Company matches $2 per $1 of employee contribution on the first 4%
• Paid Time Off Programs include vacation (12 Days), sick (24 Hrs) & personal time (16 Hrs) plus 11 paid holidays
• Opportunities for professional and personal development & growth include tuition reimbursement
• Support our current customers who are the top 25 pharmaceutical companies in the world

Job Summary:

The Regulatory Affairs Specialist is directly responsible for supporting compilation, preparation, organization, and filing the submission of regulatory related documents and reports. This position is responsible for supporting the maintenance of Chemistry, Manufacturing and Control sections of regulatory submissions to global and domestic regulatory agencies.

Essential Duties and Responsibilities:

• Maintains an understanding of current federal, state, local and/or company regulations applicable to BioSpectra and BioSpectra products.
• Supports Compilation of Modules 1, 2 and 3 of the eCTD filings.
• Ensures all drug master files, veterinary master files, and active substance master files are current.
• 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.
• Remain 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.
• 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.
• Assists with the development and evolution of the Regulatory Program procedures and policies.

Qualifications:

• Four-year degree in Science or related field.
• 1 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 other applicable US FDA regulations and guidance documents related to pharmaceutical ingredient manufacturing.
• 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.

Physical Requirements:

• Standing for extended periods.
• Walking for extended periods.
• Sitting.
• Keyboarding.
• Regular lifting of up to 10 lbs.
• Occasional lifting of up to 25 lbs.

Work Hours:

• Exempt Position; Shift 8am to 4:30pm.
• Minimum of 40-45 Hours Week, or other agreed upon documented schedule.
• Ability and willingness to work from all BioSpectra facilities.

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