Head of Regulatory CMC Drug Development

OVERVIEW

To meet accelerating growth, Enkrisi is seeking a leader to provide oversight of CMC regulatory strategy and investigational and marketing applications. The firm serves the needs of emerging biotech in the US, most of whom do not yet have major products approved and on the market. The firm advocates CMC strategy directs CMC Operations and develops CMC submission content that represents the best interests of biotech, focusing on the critical issues affecting smaller emergent companies and building programs to enhance their development.

The ideal candidate will serve as the CMC regulatory subject matter expert for the firm and must be willing and able to be “hands-on” by rolling up sleeves and being detail-oriented, providing independent or team submission authoring.

The ideal Candidate has well-developed and demonstrable writing skills, understands strategic communications, and with the ability to “simplify the complex.” Strategic/critical thinking skills, as well as initiative, are a must for this role! Additional skills needed include a sense of urgency (milestone/timeline driven) and the ability to ask questions and probe further.

Roles and Responsibilities 

You might be a good fit if you have the following:

• Addressed and resolved complex regulatory issues arising in drug discovery/development programs
• Worked collaboratively in a multi-disciplinary team environment, including with small emerging sponsors
• Provided the strategy and knowledge needed to ensure that CMC practices are carried out per the requirements of regulatory bodies, such as the FDA and EMA
• Provided knowledge, understanding, and interpretation of regulations so that the drug has the best chance of being approved
• Been involved with authoring and compiling regulatory submissions and interacting directly with Agencies
• Established individual client-specific strategies and prepared technical documents (authored and/or reviewed) to ensure successful CMC packages
• Kept abreast of current data, trends, regulatory knowledge, and developments
• Provided advanced leadership skills and executive presence to develop the infrastructure, systems, processes, and policies to effectively deliver innovative and customized regulatory solutions to meet client’s needs
• Established individual client-specific strategies and author and reviewed technical documents to ensure successful CMC packages
• Maintained client satisfaction by addressing quality and regulatory matters

Qualifications

Proven track record of regulatory leadership in the CMC areas of strategy and submission authoring required.

• Experience with both small and large molecules preferred
• Direct experience with regulatory agency negotiation and meetings with excellent communication skills
• Ability to establish a home office and work autonomously remotely
• Scientific background/regulatory understanding
• Problem-solving and negotiation skills

Preferred Skills

• Proven track record Regulatory leadership in the CMC areas of strategy and submission authoring required
• Experience with both small and large molecules preferred
• Direct experience with regulatory agency negotiation and meetings with excellent communication skills
• Ability to establish a home office and work autonomously remotely
• Scientific background/regulatory understanding
• Problem-solving and negotiation skills
• Knowledge of a variety of dosage forms is a plus.