Senior Manager, Regulatory Affairs

We are seeking an accomplished and results-driven Senior Manager of Regulatory Affairs for our client, one of the leading pharmaceutical companies in the San Francisco Bay Area. The post represents an excellent opportunity to take part in creative therapeutic product development and commercialization within a challenging and dynamic environment.

Overview

The Senior Manager Regulatory Affairs will lead the efforts in developing and executing regulatory strategies for our client's product portfolio. Therefore, we need an individual with expertise in global regulatory requirements, as well as excellent communication and interpersonal skills to facilitate effective working relationships within cross-functional teams.

Responsibilities

• Develop and execute global regulatory strategies for assigned products throughout their lifecycle.
• Regulatory guidance to cross-functional teams will be provided by this role on a...

Global Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in the Kansas site before the end of Q1 2025, we’re searching for an experienced Regulatory Manager to support their next growth stage.

This is a 100% on-site role with relocation assistance available in Kansas. This is an exceptional opportunity to relocate out of any major busy cities to join one of America’s most affordable states in the Heartland of America. As the Senior Regulatory Manager, your role involves managing client and stakeholder expectations, navigating regulatory processes, and creating solutions for complex regulatory challenges that contribute to producing high-quality pharmaceutical products.

Role: Senior Regulatory Affairs Manager

Location: Kansas City, KS

Responsibilities:

• Supports...

Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.

We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.

We promote a trusting and appreciative company culture and value colleagues...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for our programs in clinical development. You will collaborate closely with the global...