Date Posted

Company

Position

Sr. Regulatory Affairs Manager

Houston, TX

  United Imaging Healthcare is a leading global medical device developer and supplier with a diversified portfolio of advanced imaging equipment and healthcare IT solutions. We are building an innovative team with the mission of developing and supplying advanced technologies and improving patient care worldwide. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Regulatory Affairs Manager will be responsible for establishing best practices in the area of pre- and post-market regulations, submissions and new product development. This position will require short-term international travel and training in Shanghai, China.

  Provide proactive leadership of all RA issues. Lead company's product certification scheme. Drives establishment registration, device listing, and submits product reports via US-FDA Unified Registration and Listing System (FURLS). Supports the annual US-FDA sites registration and listing review and responds to RA information requests. Ensures marketing approval activities are in accordance with FDA requirements. Interprets FDA regulations and regulatory requirements to ensure product regulation compliance. Aware of and complies with the UIH Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position. Oversees complaint handling procedure. Provides company with support and guidance on medical device regulations. Maintains dashboards of activities and provides data for metrics.

JobID: 1002

  Responsible for the preparation of documents for publishing, compilation, and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA and EMA), including but not limited to IND, BLA/NDA/MAA, IND amendments, meeting requests and briefing books. Knowledgeable of eCTD templates and structure of Modules (1-5).  Experienced with DocubBridge software, minimum of 3 years. Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions. Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions.  Proper archiving of regulatory submissions Knowledge of current regulations, laws and guidance both US and ex-US. Responsible for interaction with team across a number of development programs. Detail oriented. Capable of developing and adhering to timelines Extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines Expert skills in MS-Office, Adobe Acrobat applications, electronic /document/data management systems. Excellent editing skills. Ability to handle multiple tasks and strong attention to detail.

Please forward CV and salary requirements to [email protected]

  The Director/Senior Director, Regulatory Affairs, under the guidance of the VP, Regulatory Affairs, works within the Operations Team with a focus on leading corporate regulatory strategies as well as executing tactical regulatory functions. Specific job functions include regulatory support of the global development and registration of the company’s products, drafting and submission of regulatory documents, license renewals, periodic updates and registrations to regulatory agencies. This role will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Externally, the Director/Senior Director, Regulatory Affairs will interface with regulatory agencies, corporate partners, consultants and vendors with regards to development, regulatory and registration strategies.

 The VP of Regulatory Affairs (RA) is responsible is responsible for conducting strategic regulatory planning for delivery of new and revised product introductions into US and international markets. The position is responsible for the life cycle management of existing products from a regulatory perspective. The VP Regulatory Affairs is the liaison between the Company and Regulatory Authorities and has responsibility for establishing, developing and maintaining relationships and communications with Regulatory Authorities, internal business management and external business affiliates. VP of Regulatory Affairs will direct and manage a team of regulatory professionals.

JobID: 10094

  Due to growth we need an experienced regulatory affairs professional with project management capabilities who can facilitate the planning, coordination, & execution of regulatory deliverables. You will be an integral member of the Clinical & Regulatory Practice, further enabling SciLucent to ensure the timely preparation of high-quality regulatory submissions, original & any subsequent later amendments, to health authorities. You will: Identify project objectives, deliverables, & milestones; Create & actively manage submissions plans & timelines; Prepare & distribute reports & trackers to communicate updates & project status; Coordinate the preparation, review, & publishing of submission documents; Conduct kickoff submission-related kick off meetings (prepare agendas, document discussions, identify action items); Coordinate/support cross-functional submission teams; Work closely with regulatory operations to execute electronic submissions; Prepare administrative documents for regulatory submissions. You must have a Bachelor¿s degree in a relevant scientific discipline (i.e. Biology, Pharmacy, etc.); Several years of regulatory or other relevant industry experience; prior project management experience with U.S. regulatory submissions; an understanding of electronic submission processes; strong knowledge of the drug development & regulation process; excellent understanding of requirements for U.S. regulatory filings; excellent written & verbal communication skills; ability to work independently & as part of a team; strong interpersonal skills & the ability to effectively work with others; & strong organizational skills.

 Grifols is looking to fill the position of Regulatory Affairs Specialist. This position will be located in Clayton, NC. The ideal candidate MUST be able to speak Spanish fluently. Hold a Bachelors degree plus 2 years of relevant experience within the Biopharmaceutical Industry. Flexible and adaptable to changing situations/projects within the company/industry; Basic knowledge of applicable laws and regulations. Ability to work under tight timelines to meet deadlines and business objectives. Superior skills with the use of MS-Office and ability to learn Regulatory specific software/electronic systems. Ability to work independently with limited supervision. High degree of attention to detail and troubleshooting skills. Knowledge of global health agency submissions requirements. Ability to work as part of the regulatory team to meet group objectives; Ability to clearly communicate verbally and in writing with external contacts that may include industry representatives, regulatory authorities at the federal, state, and local levels. Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications. If you feel you have these skills and knowledge please apply directly to the link.

  United Therapeutics is seeking a highly motivated individual for the Regulatory Affairs Associate/Senior Regulatory Affairs Associate role to assist with the global regulatory activities for PAH therapies. This position will prepare and maintain new and existing regulatory applications, including investigational and marketing applications (INDs, NDAs, etc.), amendments, supplements, and other submissions in compliance with health authority regulations, interact with cross-functional teams, and contribute to regulatory strategy.

JobID: R01599