Director, Regulatory Operations – Submission Publishing

Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

The Director, Regulatory Operations – Submission Publishing is responsible for ensuring submissions are successfully delivered to Health Authorities by established timelines of the highest quality, managing the regulatory operations publishing group and providing oversight on the use and maintenance of various submissions tools.  You have a thorough understanding of regulatory processes and submission requirements with the ability to motivate and develop a team to achieve departmental and corporate objectives.

Key Responsibilities: 

• Streamline submission planning to ensure timelines, submission content, and target submission dates are clearly communicated between regulatory strategists, regulatory coordinators, and submission publishing team. Collaborate with cross-functional teams to compile submission documents and resolve issues.
• Provide guidance and support while managing all activities for internal publishing team and external partners in order to successfully prepare, build, and dispatch submissions on time with the highest industry standards.
• Contribute to the Regulatory Operations technology roadmap and recommend and execute on strategies to maximize submission publishing processes.
• Utilizing strong analytical skills, identify issues and implement effective solutions, as well as identifying more efficient ways of working/driving process improvement.
• Support the development and growth of the submission publishing team, define goals in alignment with department and company objectives, and manage publishing team performance.
• Partner with IT and QA to move submission system initiatives forward.
• Maintain knowledge of regulatory guidelines and industry standards related to electronic submissions (eCTD) and publishing tools (e.g., eCTD software, Adobe Acrobat). Stay abreast of emerging trends and best practices in regulatory submissions publishing and contribute to process improvement initiatives.
• Coordinate with external vendors and consultants as needed for submissions-related activities.
• Support other Regulatory Operations projects and activities as needed.

Requirements:

• 10+ years Regulatory Operations experience in the biotech/pharmaceutical industry with a solid understanding of drug development. Strong understanding of global regulatory requirements and guidelines (FDA, EMA, ICH).
• 5+ years hands-on eCTD publishing experience; RIM Smart experience a plus. Overall proficiency in various electronic submissions tools and software (e.g., eCTD, document management systems).
• BA/BS degree or equivalent experience.
• Publishing experience with major submissions (IND, NDA, BLA, etc.) as well as post-marketing submissions. Global submission publishing experience (MAA, etc.), a plus.
• In-depth experience with Veeva Vault RIM functionalities (Submissions Planning, Submissions Archive, Submission Content Plans, etc.).
• Document publishing expertise (MS Word formatting, PDF conversion, linking, etc.).
• People management experience, particularly for team of submission publishers and leading regulatory submissions projects.
• Strong oral and written communication skills. Excellent project management skills with the ability to prioritize tasks and meet deadlines coupled with strong communication and interpersonal skills, to effectively collaborate across functions and influence outcomes. Skilled in developing collaborative internal and external relationships.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
• Ability to multi-task and adjust priorities quickly while working under tight deadlines.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project), sharing tools (e.g. SharePoint), and electronic document management systems (Veeva).
• Detail-oriented with a focus on quality and compliance.
• Commitment to company values and culture.

Work Environment:

• Remote-based.
• Dynamic, interactive, fast-paced and entrepreneurial environment.
• May require up to 20% travel.

Compensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $215,000.00 - $225,00.00.