Regulatory Affairs Consultant

Job Description

Overview:The Regulatory Scientist provides support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary based on job level and regional:Participate in global regulatory team meetings as appropriate.Advise the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.Act as back-up for contact with Regulatory Agencies as needed.Draft cover letters for Regulatory Agency communication.Assist in the preparation of meetings with Regulatory Agencies.Liaise with LOCs, ensuring responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy.Assist in the development and improvement of processes related to regulatory submissions.Review clinical trial plans and protocols to ensure alignment with regulatory requirements.Provide regulatory support throughout the registration process and life-cycle management.Advise the team on required documents and submission strategies (in collaboration with LOCs as appropriate).Assist with timely availability of submission documents and ensure that all document components are in place on time.Draft and review some document content (depending on level of regulatory knowledge/expertise).Prepare, hold, and lead cross-functional team meetings as appropriate.Understand submission details and liaise with Submission Management.Review and approve submission plans.Review submission documents to ensure compliance with regulatory requirements.Assist with submission and acceptance of the submission package.Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.Serve as the Regulatory representative on specific multi-discipline teams.Keep abreast of current and pending approvals in specific therapeutic areas and remain knowledgeable of laws, guidance, and requirements related to those areas.Requirements:An advanced degree (MS, Pharm D, PhD) is highly preferred; a minimum of a Bachelor's Degree is required.1+ year relevant experience with an advanced degree OR 4+ years with a Bachelor's Degree is required. Pharmaceutical industry experience is preferred.Understanding of the drug development process is required.Understanding of the regulatory submission and approval process is required.Knowledge of the regulatory environment, US guidelines, and practices is required.Direct experience in regulatory affairs is desirable.Candidate must be able to work successfully within a team environment and as an individual contributor.Project management, oral & written communication skills, organization, and multi-tasking skills are required.Additional Information

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