Senior Director, Regulatory CMC

Overview

PepGen is at an exciting time in our development. This role is for a motivated and team-oriented individual who flourishes in an environment where they can help lead and shape our future.

As an integrated member of the PepGen team you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the development and life cycle management of investigational products, including risk management and compliance requirements, authoring, compiling and / or reviewing CMC modules for regulatory submissions for investigational new drugs, clinical trial applications, and meeting briefing documents and responses to health authority queries.

In addition, working closely with our CMC and quality organization, you will provide valuable regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.

Note : This is not a remote role. We like to work together and operate in a hybrid model in office Tue, Weds & Thurs each week.

About the Team

As a member of this team, you will feel the excitement, passion, and pure joy that comes from being part of an innovative company with a focused mission.

Responsibilities

• Ability to be able to command the attention and lead higher level managers and senior subject matter experts.
• Demonstrated leadership, problem-solving abilities, the ability to be flexible, and foster strong team relationships, with excellent written and oral communication skills.
• Independently motivated, effective analytical and problem-solving skills, with the ability to navigate complex clinical regulatory challenges.
• Detail-oriented mindset and exceptional organizational skills, augmented with adaptability to dynamic and evolving regulatory landscapes.

Requirements

About PepGen

PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

EEO Statement

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies

PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.

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