14 Aug
|
Freyr Solutions
|
India
14 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 environment. 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 collaboration with functional sub-teams. Maintain doc plan/content plan to ensure timely hand-off of final documents from functional sub-teams.
Manage authoring, reviewing and approval process for regulatory owned documents as necessary.
Populates Content Plan template with specifics for submission and metadata.
Qualifications & Experience
Bachelor’s degree in Pharmaceutical Sciences, Medical Sciences, or a related scientific discipline , or equivalent experience
Experience
~4–6 years of experience in the pharmaceutical or life sciences industry
~ Minimum 2 years of project management experience , preferably in Regulatory Affairs or Regulatory Operations
~ Experience supporting regulatory submissions for major markets (US, EU, etc.)
Experience supporting submissions such as IND, NDA, BLA, EU MAA, EU variations
Familiarity with regulatory project planning and submission tracking
Experience with Microsoft Project or equivalent tools (preferred)
Proficiency in Microsoft Office (Word, Excel, Outlook)
Competitive salary and benefits package.
Flexible work environment (remote or hybrid options available).
Opportunity to work with a global team and contribute to impactful projects.
Continuous professional growth through training and development programs.
Inclusive, collaborative, and innovative work culture.
Opportunity to work on impactful projects in a dynamic and innovative environment.
Competitive salary and benefits package, including performance-based incentives.
Versatile work options to support work-life balance.
Continuous learning and professional development opportunities.
Collaborative and inclusive work culture that values diversity.
📌 Regulatory Projects Manager (India)
🏢 Freyr Solutions
📍 India