Director, Head of Regulatory CMC Technical Writing

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health bene fits.

Position Summary

Rocket Pharma is seeking a Director, Head of Regulatory CMC Technical Writing who will be responsible for CMC technical document review and writing, authoring and compiling CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.

Responsibilities

• Build and manage an efficient technical writing team to support regulatory submissions and technical documents
• Provide regulatory and technical writing expertise to ensure creation of strong technical and regulatory documents
• Establish and implement templates and processes to support efficient technical writing
• Train cross-functional teams to support development of strong technical and regulatory documents
• Author CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents, responses to information requests) to support the timely submissions of investigational and marketing applications.
• Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of BLA/MAA, IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents.
• Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
• Provide review and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
• Ensure submissions are complete, accurate, and comply with applicable regulatory requirements and expectations.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
  
  

Qualifications

• Minimum Bachelor's degree in Chemical and/or, Biological Sciences/relevant discipline. M.S.,Ph.D, or PharmD preferred.
• 10-12 years' experience in CMC regulatory filing experience is required.
• Strong technical writing skill is required.
• Prior experience in cell/gene therapy is strongly preferred.
• Prior experience in the preparation of CMC sections of regulatory dossiers in eCTD format is required, prior BLA filing experience is strongly preferred.
• Prior working experience with regulatory document formatting and eCTD viewer is required.
• Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure.
• Ability to communicate technical information from multiple sources into written documents suitable for regulatory authorities.
• Ability to work effectively in a cross functional team environment.
• Excellent verbal/written communication skills.
• Proven planning and organizational skills.
• Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
• Detail oriented.
  
  

Compensation

Salary Range: $200,000 - $230,000

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.