Job Title : Regulatory Associate
Locations : Remote
This role is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients.
This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across components, partner companies, and within relevant ministries of health.
The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application.
It is expected that this position embrace corporate transformation initiatives and is capable of representing Global Regulatory Affairs.
Provide Regulatory & Drug Development Expertise
Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for global submissions. This includes but us not limited to all submission types (Ad Promo, INDs, NDA, BLAs, NDSs,other eCTD MAAs, Renewals and Variations), and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification
Guide and influence development team and function regarding internal and Agency registration management processes and requirements
Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate. Records include: tracking the submission status of pending applications and commitments as well as all communications with regulators (Incoming correspondence and records of contact).
Serve as the regulatory operational lead for registration planning and execution including but not limited to: planning sessions and status updates, team operation meetings and local department planning.
Own the routine compliance submissions and processes for molecules within areas of assigned responsibility (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions).
Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process.
May provide qualified candidates outside state.
Qualified candidates are accepted from all US regions.
Candidates must have highspeed internet connectivity for role and to support daily work.
Thanks & Regards,
JayVukkusila - Senior Technical Recruiter
Office : +16096864593
For moreopportunities check out: http://www.realsoftinc.com/careers.html
Real SoftInc / Diversity Direct
68 CulverRd., Suite 100
MonmouthJunction, NJ 08852.
Real Soft Inc.
Why Work Here?Incorporated in 1991, Real Soft Inc. (RSI) is a privately held talent agency meeting the talent needs of Fortune 500 firms across the US. We are headquartered in NJ and use recruiters both in NJ and offshore in our facility in Bangalore, India to contact candidates. Any questions or help? Reach us at firstname.lastname@example.org. Looking forward to working with you!
Awesome company, good learning experience, Fortune 100 firm on resume