Senior Regulatory Project Manager

About Freyr

Freyr Inc. 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.

Why Join Freyr:

Be part of a global, fast-growing organization that operates in over 150 countries.

Opportunity to work on impactful projects in a dynamic and innovative environment.

Competitive salary and benefits package, including performance-based incentives.

Flexible work options to support work-life balance.

Continuous learning and professional development opportunities.

Collaborative and inclusive work culture that values diversity.

Lead Regulatory Project Manager

Location: Remote

Job Type: Permanent/FTE

Position Overview:

Key Responsibilities

Partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for high-complexity programs/products are established and executed seamlessly.

Expertly lead cross-functional project submission working groups (SWGs) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs.

Provide expert project management leadership, oversight, direction, and planning.

Directly support the program GRL by ensuring project management and regulatory operational support for the asset.

Perform regulatory operational activities and oversee vendors providing operational support for assigned programs.

Provide additional support as required.

Minimum Requirements

Education:

Bachelor's or Master's degree in Pharma/Medical or another associated scientific discipline OR equivalent.

Experience:

Minimum 8 years in the Regulatory field and 5 years of demonstrated project management skill sets.

Expertise with project management software and tools, e.g., MS Project, SharePoint, OneNote. Additional experience with OnePager and Office Timeline preferred.

Proven experience driving submissions for major markets (e.g., US IND, NDA, BLA, EU MAA, EU variations).

At least one major (original or supplement) and several minor (amendment) filing experience in one or more jurisdictions.

Experience with eCTD and submission timeline management is required.

Skills:

Strong conceptual and analytical thinking skills.

Deep understanding of global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process.

Proficiency in MS Office (Word, Excel, Outlook).

Ability to multitask, prioritize competing assignments, and work under deadlines in a fast-paced environment.

Excellent verbal and written communication skills; ability to prepare effective presentations with focused messaging.

Demonstrates strong collaboration and interpersonal skills with the ability to work across departments and external organizations.

Fluency in English (written, verbal, reading).

What We Offer:

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.