Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Post : Regulatory Affairs Associate II
Job Description
Regulatory Compliance
A rotation through Regulatory Compliance will provide insight into the group’s broad responsibility of providing guidance and oversight related to health authority (FDA, EMA, MHRA, etc.) regulations that impact the Gilead R&D organization. As a result, this rotation will include an introduction into clinical research auditing to ensure that the rights, safety and well-being of study subjects are protected and the data that are collected is credible. Auditing clinical trial activities against applicable requirements ensures a successful regulatory submission and identifies opportunities for process improvements. In this rotation, additional areas that interns will be exposed to include, but are not limited to, preparing and conducting audits, writing audit observations, creating an audit report and reviewing audit report responses, gaining an understanding of compliance oversight of pharmacovigilance, regulatory submissions, biometrics, and computerized electronic systems supporting all these areas. An understanding of these areas also requires that you become familiar with the concept of a Quality Management System and writing Standard Operating Procedures. Upon completion of this rotation you will be prepared for a potential position within Regulatory Compliance at Gilead.
Regulatory Affairs, CMC
A rotation through Regulatory Affairs CMC (chemistry, manufacturing and controls) will provide insight into the lifecycle of drug development from the initiation of clinical studies in humans through post approval activities from a chemistry and manufacturing perspective. Assignments may include supporting CMC submissions with an emphasis on learning clinical and commercial change control assessments, preparation of documents for submissions and distribution of regulatory approval notifications. There will be exposure to the CMC aspects of investigational new drug applications (INDs) and new drug applications (NDAs) and their ongoing maintenance. The associate will learn about workflows and procedures related to document creation by interdisciplinary scientific teams and how information on drug manufacturing is communicated to Regulatory Agencies. There will be extensive use of Gilead systems for regulatory document management and tracking health authority inquiries.
Regulatory Therapeutic Area Liaison
The rotation within a Regulatory Affairs Therapeutic Area Group will provide an opportunity to gain valuable experience in the preparation of submissions to US and potentially other global regulatory authorities in support of the clinical development of new investigational agents and/or life-cycle maintenance of Gilead’s current marketed medicinal products. This work will provide an insight into ICH, US, and/or regional regulatory requirements; it also must be conducted in accordance with company policies and procedures. The role will typically require interaction with functional groups outside of Regulatory Affairs in the preparation of regulatory documentation that may include investigational new drug applications (INDs) and updates, protocol reviews, safety reports, and new drug applications (NDAs), supplements and annual reports.
Excellent verbal, organizational, communication and written skills are required and ability to work on a number of projects within tight timelines. A strong scientific background is important to facilitate the preparation of the scientific and administrative regulatory documentation that is required to support new product development, registration and life-cycle management. Background knowledge of the various therapeutic areas within Gilead is helpful, but not essential.
Regulatory Project Management
Under the direction of a Senior Regulatory Affairs Project Manager, and in conjunction with the Regulatory Project Lead, the Rotational Associate in Regulatory Project Management will develop and maintain detailed timelines for cross-regional regulatory activities and submissions for assigned therapeutic areas, and assure planning and co-ordination of activities via the Regulatory Submission Team. The RPM Rotational Associate in will be responsible for:
• Coordinating, prioritizating and tracking of regulatory activities and submissions associated with the company’s research, development and post-marketing activities.
• Fostering effective and productive communication among various Regulatory Affairs groups including Regulatory Regional Leads, Regulatory CMC representatives, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas as appropriate.
• Working with Regulatory Regional Leads to assure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
• Tracking regulatory commitments and timelines for maintenance activities such as Post-marketing Commitments and Follow-up Measures, and assuring appropriate submissions are made in accordance with applicable requirements and deadlines.
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Regulatory Affairs, Labeling
Under the direction of a Regulatory Affairs Labeling Lead, the Rotational Associate provides support in the preparation and maintenance of assigned product labeling for the company’s marketed and pipeline products. This includes managing the Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), and US Prescribing Information (USPI) for assigned products and supporting activities such as the cross-functional labeling review and approval process and labeling activities with partner companies. The RA Labeling Rotational Associate will be responsible for:
• Support the maintenance and development of the CCDSs, CCSIs, and USPI documents for multiple assigned products in accordance with FDA/applicable Health Authority labeling regulations.
• Support of the cross-functional core labeling review and approval process for assigned products in accordance with corporate review and approval processes, such as the scheduling of routine and exceptional meetings with senior personnel and the compilation and distribution of meeting materials in a time-sensitive manner.
• Distribution of the CCDS for assigned products to appropriate individuals within Gilead and to Gilead’s distributors, partners, and licensees; and tracking and documenting receipt by each external party for every version of the revised CCDS.
• Coordination of the generation of US labeling documentation in Structured Product Labeling (SPL) format for assigned products as part of sNDA submissions and approvals.
• Support the RA Labeling Lead in representing Regulatory Labeling on Regulatory Affairs project teams, at cross-functional submission/project team meetings and joint labeling/safety meetings with partner companies.
• Entering information for assigned products in an electronic label change tracking system and archive labeling documents and update label histories.
Regulatory Affairs, Advertising & Promotion
The Rotational Regulatory Associate in Regulatory Affairs, Advertising and Promotion is responsible for providing operational support in the area of commercial regulatory affairs. Specific responsibilities include:
• Manage the submission of branded promotional materials for marketed prescription drug products to FDA's Office of Prescription Drug Promotion (OPDP) at the time of first use.
• With team, manage the submission of subpart H and launch advisory submissions to FDA/OPDP.
• Track and adhere to strict timelines for FDA/OPDP submissions.
• Collaborate with cross-functional partners to ensure the publication of compliant, high-quality, and timely FDA/OPDP submissions.
• Manage the Regulatory Affairs, Advertising and Promotion promotional PI verification process.
• Track and summarize relevant internal metrics.
Essential Duties and Job Functions:
In addition to the responsibilities above, this position also requires the ability to:
• Initiate and contribute to local process improvements, which have an impact on the working of the Regulatory Affairs, Advertising and Promotion group.
• Establish and maintain effective working relationships within the Regulatory Affairs, Advertising and Promotion group and across the Regulatory Affairs organization.
• Participate in group meetings and present project status updates to group.
• Help create and maintain internal archives for the Regulatory Affairs, Advertising and Promotion group.
• Contribute to the monitoring of the Regulatory Advertising and Promotion environment; with manager, provide updates to the group on FDA/OPDP notices and enforcement letters.
• Support members of the Regulatory Affairs, Advertising and Promotion group by conducting Regulatory specific research, including FDA/OPDP enforcement precedent.
• Work is performed under the general supervision of qualified Regulatory Affairs personnel; the ability to work independently is required.
• Must have the technical ability to quickly become proficient in the use of controlled regulatory document management systems; previous experience a plus, but not required.
• Experience with FDA eCTD submission structure a plus, but not required.
• Excellent organization skills and the ability to work on a number of projects with tight timelines is required.
• Must be able to consistently perform work requiring a high level of attention to detail.
• Excellent verbal, written, and interpersonal skills are required.
Candidate Profile
5+ years of relevant industry experience and a BA or BS.
Degree in a scientific field is preferred.
Additional Information:
Requisition ID: Foster City
Job Location : R0003338
Industry Type: Pharma
Functional Area: Regulatory Affairs
End Date: 28th April, 2018
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