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RCM Technologies CMC Regulatory Tech Writer in Waltham, Massachusetts

Reference # :21-00351Title :CMC Regulatory Tech WriterLocation :Waltham, MAPosition Type :ContractExperience Level :Start Date / End Date :05/04/2021 / 11/30/2021 DescriptionContractor, Regulatory Chemistry Manufacturing and Controls (CMC) Technical WritingCompany/Position DescriptionOur Client is an oncology-focused biopharmaceutical company dedicated to improving the lives of patients with cancer. Our team of passionate associates develops and will commercialize safer and more effective supportive care agents and therapeutics. We take our responsibility to patients seriously. The Regulatory Affairs contractor will ensure that our Client is executing regulatory strategies and supporting interactions with regulatory authorities appropriately. This position reports to the Director of CMC Regulatory Affairs Writing and is responsible for the following:Key Responsibilities

  • Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects

  • Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects

  • Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post-approval supplements and variations

  • Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, MA) and preparing BLA's

  • Prepare and coordinate the writing, review and approval of submission-ready documents

  • Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations

  • Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copyediting check

  • Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data

Abilities Needed for Success

  • Proven ability to work with a high level of integrity, accuracy, and attention to detail

  • Strong problem-solving skills to evaluate technical information and identify appropriate regulatory actions with limited supervision

  • Self-motivated, assertive, and self-confident with the ability to act with a sense of urgency and passion

  • Ability to influence decision-making via negotiating, advocating, and being an active listener

  • Strong organizational skills in order to maintain a high level of productivity, innovation, and a sense of urgency to ensure assignments are completed on-time and on-budget with a high level of quality

  • Ability to work independently with minimal supervision as well as part of a team environment

  • Ability to make thoughtful, integrated, work under pressure, make timely and meaningful decisions and take corresponding actions

  • Willingness to work collaboratively by incorporating diverse perspectives and in order to strengthen decision-making

  • Proactively seeks out and recommends process improvements

  • Entrepreneurial, enjoys working in a fast-paced, small-company environment

  • Proven ability to manage multiple projects, identify and resolve regulatory issues

  • Ability to balance regulatory objectives with business objectives

  • Ability to influence the regulatory team in a positive way

  • Ability to take disparate inputs and drive them into one cohesive strategic regulatory decision

  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company

  • Resourceful, creative, enthusiastic, and results-oriented

  • Strong interpersonal skills and the ability to effectively work with other departments and vendors

  • Positive and energetic attitude

Job Requirements

  • BA/BS in scientific or technical discipline or advanced degree

  • At least 3-5 years of biopharmaceutical regulatory experience

  • Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance

  • Thorough understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NCE/NME targets and marketed products

  • Experience preparing CMC sections of INDs, NDAs, and supportive amendments and supplements (ICH Modules 2 and/or 3)

  • Thorough understanding of change management processes and regulatory requirements

  • Strong problem solving and diplomacy skills

  • Exposure to regulatory requirements for biologic product development is highly desired

  • Excellent project management skills

    RCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.

    #Monster

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