Job Description SummaryThe Manager, Regulatory Affairs – Global Labeling is responsible for developing and executing global labeling strategies for assigned PDx products, with primary accountability for US FDA labeling activities and US Prescribing Information. The role partners
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Line of ServiceAdvisory Industry/SectorNot Applicable SpecialismCustomer Management LevelAssociate Job Description & Summary Contribute to creating a better tomorrow The only way we can tackle the challenges of this fast-changing world is with passionate people. Led by
Position Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the
JOB SUMMARY The Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambics development programs. The role will prepare and oversee high-quality CMC content for regulatory submissions, provide
Venture outside the ordinary - TMX Careers The TMX group of companies includes leading global exchanges such as the Toronto Stock Exchange, Montreal Exchange, and numerous innovative organizations enhancing capital markets. United as a global team,
YOUR CONTRIBUTION In the role of Head Regulatory Affairs Regions (m/f/d), you contribute to the development and success of the Merz Therapeutics organization. You lead a group of 17 Regional Regulatory professionals (organized in 2 Teams, e.g. one
Join the Mitsubishi Motors North America (MMNA) Team! At Mitsubishi Motors NA, we are driving innovation, quality, and excellence in the automotive industry. Our commitment to delivering cutting-edge vehicles goes hand in hand with our dedication
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform
ABOUT TIDE At Tide, we help SMEs save time and money in the running of their businesses by not only offering business accounts and related banking services, but also a comprehensive set of highly usable and
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced
Position Summary: The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for
Position Summary: The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering
Senior Manager, Regulatory Affairs – Japan Alnylam K.K. Overview: The Senior Manager, Regulatory Affairs, Japan reports to the Head of Regulatory Affairs and plays a key role in supporting the development and execution of regulatory strategies for development and/or commercial
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week No relocation is provided for this opportunity Who We Are: At West, we’re a dedicated team that