Senior Manager, Regulatory Affairs - CMC

Innoviva Specialty Therapeutics; Waltham (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Regulatory CMC Technical Writing and Submission Management. This pivotal role involves authoring and managing CMC sections for global regulatory filings, ensuring compliance and high-quality documentation. The ideal candidate will have a strong background in regulatory processes and technical writing, along with excellent collaborative skills to work with cross-functional teams. Join a forward-thinking company dedicated to innovative solutions in critical care and infectious diseases, where your contributions can make a significant impact on patient care.

Qualifications

• 3-5 years of experience in authoring CMC sections of regulatory filings.
• Demonstrated competency in clear and concise technical writing.

Responsibilities

• Support the authoring of high-quality regulatory CMC documentation.
• Manage regulatory CMC submission processes and timelines.

Skills

Regulatory CMC Documentation

Technical Writing

Cross-Functional Collaboration

Project Management

Regulatory Requirements Interpretation

Education

BS in Chemistry

BS in Pharmaceutical Sciences

BS in Regulatory Affairs

Tools

Veeva Vault RIM

StartingPoint Templates

SmartSheet

Job description

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering serious, difficult-to-treat illness

Our products marketed in the U.S. include:

GIAPREZA (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

XACDURO (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.

XERAVA (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).

Our latest addition to the Company's expanding antibiotic portfolio is ZEVTERA (ceftobiprole), a newly approved advanced-generation cephalosporin antibiotic. ZEVTERA is the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). We anticipate a U.S. launch in mid-2025.

Innoviva Specialty Therapeutics development pipeline includes zoliflodacin, an investigational first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea infection in patients.

At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make a difference.

Summary of Position:

The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings for all assets at Innoviva Specialty Therapeutics. This role requires a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements, while collaborating with cross-functional teams to meet technical writing and submission management objectives.

Responsibilities:

• Support the CMC regulatory writing for high-quality and compliant regulatory CMC documentation (e.g., INDs, CTAs, MAAs, NDAs and their amendments/variations/supplements, as applicable) within defined timelines
• Support Regulatory CMC submission management
• Support determination of regulatory and scientific/technical requirements for CMC submissions
• Maintain knowledge of CMC regulatory requirements for drug development through post-approval and annual updates

Experience & Education:

• BS in Chemistry, Pharmaceutical Sciences, Regulatory Affairs or other relevant fields
• 3 - 5 years of experience in authoring CMC sections of regulatory filings
• Demonstrated competency in clear and concise technical writing ability
• Understanding of CMC manufacturing documentation requirements
• Experience using Veeva Vault RIM for the preparation of regulatory documentation preferred
• Experience using StartingPoint Templates preferred
• Experience using SmartSheet preferred
• Experience with regulatory submissions and requirements, including eCTD documents required for INDs, NDAs and MAAs, supplements and briefing documents

Skills and Abilities:

• Ability to read and interpret regulations and guidance
• Excellent team interaction skills and ability to work successfully in a cross-functional team
• Ability to work in a dynamic environment with a high degree of flexibility
• Independent management of projects
• Well organized, flexible, and able to communicate effectively within CMC functions and Regulatory affairs, both spoken and in writing
• Knowledge of ex-US regulatory requirements preferred

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.