• Clinical Development Manager

    Location US-NJ-Bridgewater
    Posted Date 6 days ago(11/9/2018 2:45 PM)
    ID
    2018-2187
    Company
    Kashiv Pharma LLC
  • Overview

    The Manager, Clinical Regulatory provides support for the development of biologics and biosimilar products while managing the entire lifecycle of the product ranging from the development of clinical strategy, execution, submission to the regulatory agencies, and following through the approval process. 
    The individual will support existing products as well as provide regulatory support for new products in the portfolio.

    Responsibilities

    • Participates in establishing regulatory strategy to support investigational products.
    • Researches, reviews, and interprets related product approvals, current regulatory guidance including Advisory Committee proceedings, to support the development of optimal regulatory strategies
    • Interacts with internal and external collaborators and consultants for various regulatory matters as needed
    • Coordinates interactions with regulatory agencies including milestone meetings, controlled correspondence, and regulatory submissions
    • Plans and coordinates regulatory submissions and activities, including pre-IND and other meetings with FDA and European Regulatory Agencies, INDs, CTAs, Annual Reports/DSUR, IND/CTA amendments; assures completeness and quality of submissions; identifies issues, suggests and implements solutions
    • Provides regulatory support for clinical operations, manufacturing, and non-clinical studies
    • Acts as the Regulatory representative on specific project teams
    • Conducts regulatory review of clinical documents, including: protocols, informed consent, and clinical study reports
    • Provides the regulatory review of non-clinical documents, including: toxicology protocols and reports, pharmacology reports, pharmacokinetic and toxicokinetic reports
    • Assist in the regulatory review of CMC requirements including: characterization methods, specifications, stability protocols, and batch records.
    • Oversees preparation, review and publishing of final submissions to meet regulatory requirements; develops or revises regulatory templates, processes and procedures to ensure compliance with regulations
    • Asist the clinical CRO capabilities with respect to protocol requirments
    • Engage with health-authorities to manage the Pre-approval inspection.
    • Guide the regulatory activities to comply with the post-approval requirements
    • Ensures submission to the appropriate regulatory authorities.
    • Complies with all applicable policies regarding health, safety, and environmental policies
    • Performs other functions as required or assigned
    • Complies with all company policies and standards

    Qualifications

    • Advanced degree in life sciences or a relevant discipline with at least 5 years’ experience in a regulatory affairs function in a biopharmaceutical company; or equivalent.
    • Must have in-depth knowledge of regulatory requirements and guidances, including FDA regulations, ICH and EMA guidelines/directives
    • Experience with the regulatory submissions process, including electronic submissions and CTD format
    • Strong analytical and problem solving skills
    • Ability to coordinate and work effectively with cross-functional teams
    • Must demonstrate excellent communication skills, including writing, verbal and interpersonal skills
    • Detail oriented. Strong organizational and time management skills; ability to adhere to timelines
    • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project
    • Demonstrated ability to quickly adapt and  learn new systems

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