Regulatory Affairs Manager

BioSpectra in Manufacturing Email Job

Job Description

Reports To:
VP Regulatory Affairs

Direct Reports:
N/A

Emergency / Absentee Backup:
VP Regulatory Affairs

Job Summary:
The Regulatory Affairs Manager is responsible for the compilation of BioSpectra’s Product dossiers in accordance with ICH, eCTD and electronic submission requirements for all domestic and global regulatory submissions.  This position is responsible for coordinating and planning the facility registration, product listing and registration and Finished Goods labeling in accordance with the applicable global and domestic regulations for BioSpectra facilities or Finished Goods.

Essential Duties and Responsibilities:
Prepares eCTD filings for submission to the US Food and Drug Administration (US FDA), EU, and other global regulatory agencies.
Continually reviews documentation associated with regulatory submission to ensure amendments to submissions are completed in a timely manner.
Maintains the schedule for regulatory submissions and ensures all submissions are complete, accurate and on time.
Meets with multiple departments at each BioSpectra facility to ensure all documentation intended for regulatory submissions are complete, accurate and provided in a timely manner.
Evaluates Finished Goods and process data to establish conclusions in support of regulatory filings.
Gathers and prepares documents intended for submission to government regulatory agencies.
Reviews Finished Goods labeling, SDS, and promotional information for BioSpectra Finished Goods available for commercial distribution and ensures its compliance to regulatory standards.
Remains current with new regulations and regulatory changes and provides any regulatory updates to management.
Provides regulatory information and references applicable regulatory guidelines to Trainers and staff as required.
Interprets regulatory standards and guidelines to provide information to support BioSpectra’s quality system and departments, as appropriate.
Prepares Master Files to submit to the US FDA, EU, or other global regulatory agencies and ensures each are current.
Prepares the annual report for drug master file and veterinary master file submissions.
Ensures Good Documentation Practices are followed on all documents prepared for regulatory submissions.
Compiles and completes all Regulatory Information Packets.
Completes all regulatory statements required for customer and regulatory agency support.
Obtains and reviews requested documents during regulatory inspections or audits.
Prepares reports for REACH registration of BioSpectra Finished Goods.
Prepares all product listing, facility registration, product label updates and facility identification for submission to the US FDA or other global or domestic regulatory agency.
Other duties may be assigned as deemed appropriate by management

Qualifications:
Bachelors of Science Degree in science related field
Minimum of 4 years’ experience in pharmaceutical regulatory affairs
Thorough understanding of cGMP and ICH guidelines
Thorough understanding of FDA and EU regulatory Submission Requirements.
Thorough understanding of eCTD Submission Requirements
Must be able to read, write, speak, and understand English
Excellent reading comprehension and writing skills
Ability to effectively present information to management and other groups

Physical Requirements:
Lift up to 20 lbs. occasionally
Prolonged periods sitting at a desk and working on a computer
Ability to see and distinguish color
Bend, stoop, and carry
Repeating motion that may include wrists, hands, and fingers

Work Hours & Schedule:
Exempt Position
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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