Hiring for Regulatory Operations Manager in San Diego, CA
Rana Kamal
Hi
Please lookup the below position and if you feel comfortable ,then please send me your updated resume
Role : Regulatory Operations Manager
Location : San Diego, CA
Start : 5-8-17
Interview : Phone, Skype/In person
General Summary:
The Regulatory Operations Manager is the technical leader for electronic
submissions who supports the Company across multiple functions with a focus on
the systems specific to regulatory submissions and reporting.
The Regulatory Operations Manager will provide technical strategies that
maximize the effectiveness of the systems to ensure efficiency and accuracy of
regulatory submissions.
A successful candidate is expected to work closely with regulatory affairs
colleagues, contract electronic publishing service providers, members of the
research, development, manufacturing, quality assurance, non-clinical and
clinical functional areas, and to represent Regulatory perspectives in
discussions regarding regulatory operations. Specifically, the candidate will
provide ongoing formatting, templates, organizational advice and guidance for
optimal submissions, and ensure quality control and timely preparation of
submissions.
A key expectation of the candidate is that he/she maintains current knowledge
of regulations and FDA and European guidance documents with respect to
electronic submissions, and provides expert advice to project teams and the
department.
Major Responsibilities:
• Supervises and/or participates in the gathering of information and the
assembly of regulatory submissions for Company’s development- and
commercial-stage products
• Oversees the preparation and completion of regulatory submissions, including
INDs, CTAs, NDAs, BLAs, safety reports, annual reports and routine amendments
in eCTD format
• Ensures that all aspects of electronic submissions and documents meet
regulatory agency and Company’s submission standards and technical requirements
• Establishes and maintains effective working relationship with electronic
submissions vendors
• Interacts with regulatory authorities for Regulatory Operations inquiries;
assists in establishing departmental standards to ensure the highest quality of
submitted information
• Provides publishing project plans and timelines for major regulatory
publishing projects
• Provides technical leadership regarding the life cycle management of
electronic submissions
• Adheres to Company’s policies and supports management decisions and goals
• Stays abreast of new technology
• Assists with the training of submission activities to all levels of
Regulatory operations staff
• Ability to QC documents for electronic submission.
Knowledge, Skills and Abilities Required:
• A minimum of six years of direct experience in a Regulatory Operations
function with experience with electronic submissions and systems.
• Demonstrated technical leadership in the successful submissions to
regulatory agencies of: INDs in e-CTD format, IMPDs, CTAs, NDA, MAAs,
BLA/Supplements, Periodic Safety Update Reports, etc.
• Demonstrated track-record in managing regulatory timelines and
coordination of publishing calendar associated with the assigned submission,
including initial quality control of submissions.
• Relevant working experience (with respect to Regulatory Operations needs)
with the FDA, Center for Drug Evaluation and Research (CDER), Center for
Biologics Evaluation and Research (CBER) or equivalent experience with similar
regulatory authorities e.g. EMA
• Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of
other software required: Adobe, XML and SML authoring tools, eCTD Software, SAS
file formats.
• Good communication skills
• Ability to multitask and manage complex projects and timelines in a matrix
within a fast-paced team environment
Rana Kamal
TECHNICAL RECRUITER
VSG Business Solutions
Email ID: ra...@vsgbusinesssolutions.com
Phone: 302-261-3207 ext 118