LCM Manager

Greetings!!!
Welcome to TechProjects. We specialize in IT system integration, supporting major public sector clients across New York State. Our focus is on delivering high-quality technology solutions while creating strong career opportunities for our employees.
We are currently hiring and looking for talented tech professionals who are eager to work on impactful and innovative projects. We offer competitive compensation, excellent benefits, and opportunities for professional growth.
We look forward to connecting with you and exploring how you can be a part of our team. 
 
Job Title: LCM Manager Location: Remote Duration: Long term 
Description of Role and Responsibilities

• In this role, you will be responsible for all local regulatory affairs lifecycle management (LCM) and maintenance activities for assigned products, including but not limited to the following:

• Variations (Administrative, Labeling, CMC, Safety, dossier harmonization): Submission strategy / provide RA Assessment through change management system / CMC Assessment / Timelines / Management of local RA requirements including implementation tasks (e.g. including grace period for supply continuity), example external compendia. Coordinate artwork changes for submission and implementation (triggered due to LCM activities). Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders   ability to articulate complex scenarios succinctly and targeted to the group

• Update Local PI

• Primary contact for Local Health Authority on delegated products

• Ensure customer success throughout the engagement
   

Required Skills:

• Bachelor s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.

• Mandatory Knowledge of region and regulation also well adheres of English language

• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously

• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables

• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions

• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.

• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedure

 Desired Education           

• Enthusiasm & confidence

• Adhere to our principles and values.

• Time Management skills.