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Regulatory Dossier Specialist

Company: CordenPharma International
Location: Boulder
Posted on: May 24, 2023

Job Description:

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Regular Full-Time Professional Boulder, CO, Boulder, CO, US 26 days ago Requisition ID: 1237 Salary Range: $83,367.00 To 107,363.00 Annually CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients. EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.SUMMARYExecutes regulatory activities for their area of responsibilities pertaining to the creation and maintenance of CMC or other regulatory dossiers. Executes regulatory deliverables and fulfills regulatory requests for all regulatory customer relations for both commercial and clinical products. Represents a commensurate level of GMP understanding and accomplishment for the projects assigned within the scope of API manufacture of peptides and general small molecules. -Executes regulatory policies consistent with U.S. and international laws and regulations. Develops and issues regulatory documents on behalf of U.S. and international agencies. Interacts with regulatory agencies during audits and during the drug filing process, as designated by regulatory management. Works as part of the Corden U.S. Regulatory Group. -Responsible for providing strong regulatory support to the site as a project team member, as assigned by the Director of Quality Assurance and Control. ESSENTIAL -DUTIES -AND RESPONSIBILITIESInclude the following. Other duties may be assigned.

  • Implements the site quality culture and vision through projects as established by the Director of Quality Assurance and Control
  • Leads and promotes the quality culture throughout the site through their interactions and consideration of internal and external customer needs
  • Serves as a supplementary contact on government regulatory audits
  • Executes the authorship of new regulatory filings for development and commercial products as required
  • Handle regulatory requests from customers in support of their regulatory strategy, as needed and directed through statements of work, or as directed by management
  • Fulfills regulatory agency requests and 3rd party regulatory staffs to provide essential regulatory and technical information, in support of regulatory filings or to address regulatory questions
  • Supports the U.S. Agent for Corden Pharma International -
  • Authors or updates CMC Manufacturing Sections. Manages project load to ensure NDA filing timelines are met
  • Provides supporting documentation for justification of changes included as part of submissions to regulatory agencies
  • Update regulatory filings on an annual basis for all API and API Intermediates. This includes generation of CMC
  • Execute systems to support drug regulatory policy, including following systems which implement regulatory strategies and requirements
  • Advises of regulatory requirements for Change Control documentation for all marketed commercial products manufactured at Corden
  • Facilitates or executes the completion of annual product reviews as needed
  • Reviews Master Process Procedures from a regulatory standpoint
  • Reviews manufacturing, packaging, and testing processes to comply with all regulatory filings and Corden SOPs, to ensure favorable quality inspections and customer satisfactionLEADERSHIP & BUDGET -RESPONSIBILITIESResponsible for providing regulatory support on new technology, new opportunities, and large projects and technology transfers.Carries out assigned responsibilities in accordance with Corden policies and applicable laws.SAFETY & ENVIRONMENTAL RESPONSIBILITIESEvery individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EDUCATION and/or EXPERIENCE -Bachelor's degree in a scientific field; or 5 years in regulatory for pharmaceuticals or equivalent combination of education and experience. Regulatory certifications preferred.LANGUAGE SKILLSAbility to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.MATHEMATICAL SKILLSAbility to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution.REASONING ABILITYAbility to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (chemical formulae, scientific equations, graphs, etc.). Ability to deal with a variety of abstract and concrete variables.CERTIFICATES, LICENSES, REGISTRATIONSDomestic and international travel may be required.PHYSICAL DEMANDSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.CORE COMPETENCIES These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
    • Regulatory expertise through education, previous experience/work product, or certification
    • Knowledge, experience, and ability to analyze regulatory requirements (both U.S., European, and ROW) and translate requirements to strategies that can be articulated and implemented within the business
    • Experience with interaction with national and international governmental authorities and agencies
    • Knowledge of current Good Manufacturing Practices, ICH Guidelines, internal procedures, and other pertinent national and international regulations
    • Excellent, verbal, written, interpretive, presentation, and interpersonal skills
    • Prefer a good knowledge of peptide chemistry, small molecule synthetic chemistry, analytical chemistry, and pharmaceutical manufacturing
    • Proactive approach to problem solving and resolutionSALARY Actual pay will be based on your skills and experience. BENEFITS
      • 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service -

Keywords: CordenPharma International, Boulder , Regulatory Dossier Specialist, Other , Boulder, Colorado

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