|Reference # : ||17-91428
||Title : ||Director of Regulatory Operations and Regulatory Process|
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||12/18/2017 / 06/17/2018
| Description |
|Job Title: Director of Regulatory Operations and Regulatory Process?|
Work Location: Princeton, NJ
Length of Assignment: 6 Months
Position Type: Contract
Job ID: 22208-1
Client: A Big Pharmaceutical Company
• Working with Client regulatory strategy and an external vendor of regulatory services, this role will ensure that appropriate regulatory processes for the management of regulatory dossiers, documents, and publishing are created, and documented.
• Responsible for ensuring a common and simplified system of document creation, review and approval is in place sufficient to comply with regulatory standards.
• Responsible for ensuring appropriate training of the relevant staff that are engaged in thes processes
• Responsible for review and assessment of the processes with the existing SOPs and regulations.
• Responsible for the review and editing of the documentation that explains the processes, ensuring clarity and appropriate detail
• Ensure that all processes are consistent with ensuring quality and appropriate quality control of the process outputs.
• Oversees short and long term global dossier management strategies for all products/projects at all phases
• Recommends departmental process and policy through oversight, review, approval, implementation and maintenance of SOPs and work practices.
• Ensures processes are in place to create dossiers on time and are of high quality, consistently meeting regulatory standards, and provides guidance to solve issues.
• Constructively challenges decision making when necessary, based upon experience and Regulatory knowledge. Influences other functions as appropriate regarding business process.
• 10 years’ experience in the management of regulatory operational work supporting new drug registration and application maintenance.
• Thorough understanding of cross-functional operational aspects of dossier planning, preparation and management. In depth hands on experience in the planning, creating, and submission of regulatory dossiers in the US and outside the US.
• Experience in creating, documenting and training on regulatory processes that underpin drug development, such as US FDA IND maintenance activities, safety data processing, regulatory submission management, medical writing, and regulatory document publishing.
• Knowledge and Experience with the Regulatory guidelines, regulations and best practices for management of global regulatory operations
• Knowledge and experience in using electronic publishing systems required to create electronic regulatory submission, document and dossier management systems
• Demonstrates strong working knowledge of global regulatory practices and requirements
• Demonstrated ability to work with, influence, in a complex and culturally diverse, dynamic environment to deliver value-added results to the organization.
• Demonstrated ability to work in an organized and consistent manner even under pressure. Demonstrated ability to effectively communicate ideas and persuade others to accomplish challenging goals and objectives.
Please apply on our company website (www.artechinfo.com) with reference to job ID, or feel free to share your most updated resume at firstname.lastname@example.org
Pharma Recruitment- Lead
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3431 | Fax: 973.998.2599
Email: Mayank.Sharma@artechinfo.com | Website: www.artechinfo.com
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com
Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us on Facebook, Twitter, LinkedIn, Google+, and YouTube