Regulatory Associate

Company: Synectics Inc.
Location: Rockville
Posted on: September 15, 2020

Job Description:

Description: Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy. Leveraging internal and external regulatory and scientific networks to problem solve. Providing input into corporate regulatory positioning including US key considerations with equipment and utilities validations. Critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to annual reports, equipment validations, briefing documents, key meeting summaries, and BLA establishment modules. Program Management - Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams. Responsible for regulatory submissions, interactions, and strategy for various US products. Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of Vaccines submissions for the asset(s). Assess the regulatory impact of Regulatory Facilities related Changes pertaining to approved commercial products Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product. Interact with internal project related teams, for Facilities related regulatory affairs aspects of a given project on technical aspects. Participate in project/product related discussions and provide strategic, scientific and regulatory affairs input, for Facilities related aspects of given project on technical aspects. Provide input into the asset specific regulatory strategy on a global scale. Provide support to the GRL via input and/or critical review of the facilities regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.Qualifications: Bachelor's degree (Science) or advanced degree 6+ years significant experience in regulatory affairs or appropriate relevant experience in scientific function combined with at least 3 years direct RA experience Knowledge and experience in US regulations pertinent to CMC Establishments/GMP Knowledge and experience in CMC Establishments/GMP/ Equipment Validations Preferred Qualifications: Pharmaceutical development or regulatory affairs experience with biologics and vaccines . Strategic Leadership - Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US.

Keywords: Synectics Inc., Rockville , Regulatory Associate, Other , Rockville, Maryland