15 Aug
|
Freyr Solutions
|
India
15 Aug
Freyr Solutions
India
About Freyr Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, innovative, and collaborative setting. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries.
At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration.
Job Title: Regulatory Project Manager (RPM) Support
Location: Remote
Employment Type: Full-Time / Permanent / Indefinite
The Regulatory Project Manager (RPM) Support will assist in managing global regulatory projects, supporting submission activities, and ensuring effective coordination across cross-functional teams. This role will contribute to the planning, tracking,
and execution of regulatory submissions while supporting Global Regulatory Teams (GRT) and Submission Working Groups (SWG) to meet regulatory milestones and timelines.
Co-leads SWGs with the designated regulatory lead for non-major global markets MAAs and supplements
Work with functional sub-teams to develop timeline based on data availability and other critical path activities. Maintain timeline during project lifecycle. Represent Project Management at Kick-off (i.e., Send call for agenda prior to meeting. Record risks raised by team members in the risk log, if assigned. Escalate major risks to GRT.
Create and maintain submission timeline in Project Plan. Perform scenario planning to identify possible outcomes based on identified risks.
Attend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignment.
Create doc plan/content plan in c
📌 Regulatory Projects Manager (India)
🏢 Freyr Solutions
📍 India