• Sr. Manager/Director, Regulatory Affairs

    Location US-NJ-Piscataway
    Posted Date 4 weeks ago(10/22/2018 11:26 AM)
    ID
    2018-2213
    Company
    Adello Biologics, LLC
  • Overview

    Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Senior Manager / Director, Regulatory Affairs to be based out of our HQ in Piscataway, NJ.

    Responsibilities

    SUMMARY:

    The Senior Manager, Global Regulatory Affairs (MRA) is part of the compliance department and reports directly to the Head, Global Regulatory Affairs. The MRA will be responsible for all assigned functions of the Regulatory Affairs (RA) group. The MRA will oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. The MRA will have previously worked in a cGXP area. The MRA will be responsible for all regulatory submissions and updates. This could be considered for a Director, Regulatory Affairs level according to experience.

     

    Essential Duties and Responsibilities:

    • Manages the RA functions for the organization.
      • Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
      • Maintain current knowledge of relevant regulations, including proposed and final rules.
      • Responsible for coordination & preparation of regulatory submissions.
      • Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals.
      • Prepare regulatory dossiers for submission to Health Authorities
      • Participate in product teams with regard to implementation of regulatory requirements
      • Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
      • Update licensing and collect information on registration instructions and regulations
      • Demonstrated experience working in cGMP, cGLP, and cGCP environments.
      • Contributes to the global Chemistry Manufacturing and Control (CMC) regulatory strategies and content plans.
      • Experience filing Investigational New Drug (IND), New Drug Application (NDA), Drug Master File (DMF), and Biological License Application (BLA) in electronic Common Technical Document (eCTD) format for sterile finished products. 

    Qualifications

    PREREQUISITES:

    Education:

    • Minimum a bachelor’s degree from a four-year university/college in chemistry, biology, engineering, or other related field.

    Experience:

    • Pharmaceutical manufacturing
    • Minimum of seven years’ experience in the field
    • Previous work in a cGMP industry

    Certifications, Licenses, etc.:

    • Regulatory Affairs Professional Society-Regulatory Affairs Certification (RAPS-RAC), preferred

     

    SPECIALIZED KNOWLEDGE AND SKILLS:
    Language:

    • Must read, write, and speak English

     

    Mathematical Skills:

    • Must be able to apply basic mathematical skills for addition, subtraction, multiplication, and division
    • General statistical calculations using Excel or other statistical programs

     

    Reasoning Skills:

    • Relies on experience and judgment to plan and accomplish goals.

      Computer and/or Technical Skills:

    • Experience with EDMS systems
    • Operation and understanding of word processing, spreadsheets, and data management
    • Presentations using MS Power Point for upper management and regulatory authorities

     

    WORK ENVIRONMENT AND PHYSICAL DEMANDS:

    General Work Environment:
    • Office space

    Noise:
    • Standard office environment noise. Some noise levels in manufacturing need to be tolerated while    conducting inspections.   

     Standing/Lifting:
    • Walking though manufacturing when required
    • No lifting requirements

    Visual:
    • No special requirements

     Stress:
    • High paced demanding environment to meet the regulatory needs of the company
     

    Travel:
    • Travel will be expected, but not to exceed 40%

      

    Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

    Notice To Agency And Search Firm Representatives  

    Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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