The Director of Regulatory Operations will play a critical and leading role in establishing internal publishing and operations capabilities. The successful candidate will provide oversight to effectively support timely and quality submissions for multiple indications performed internally and externally to ensure compliance to all regulatory authorities and all aspects of electronic submissions and documentation that meet regulatory agency submission standards and technical requirements. This person will oversee and coordinate the content finalization and review within cross-functional teams and subject matter experts, compile, prepare and review the various documents for content completeness and compliance with all the regulatory reporting requirements and publishing.
- Maintains current regulatory knowledge of submission requirements, content, format and publishing for submissions to regulatory authorities, instructs the team of changes to process and implements appropriate regulatory strategies to mitigate risks
- Ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines and for regulatory application types including INDs, NDAs/BLAs, MAAs, JNDA, NDS and any related amendments/supplements.
- Maintains expertise in publishing best practices and manages relationships with vendors in the evaluation and implementation of regulatory submission processes, systems and software
- Works independently with program and project teams to design and execute high quality submission plans, ensuring that timelines and technical requirements are mutually understood and in line with current standards
- Defines and implements standards and process efficiencies for submission management including drafting and adherence of SOPs and work instructions; ensures application of best practices standards are understood and followed by applicable departments/stakeholders and vendors
- Operates as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory staff and representatives from cross-functional teams
- Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with regulatory authority requirements and company standards. Acts as direct liaison with contributing departments to facilitate effective management of submissions.
- Oversees development and implementation of standards for publishing and submission process by assuring completeness and quality submissions from operational perspective and identifying solutions for regulatory submissions.
- Oversees compliant archiving of all regulatory documents and regulatory correspondence, including developing archiving system and processes for regulating access to archives and overseeing maintenance of all correspondence logs.
- Bachelor’s degree (advanced degree preferred) in a life science field (Biology, Chemistry, or Pharmaceutical sciences)
- 12+ years’ experience in pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience)
- 10+ years Regulatory Affairs experience in drug development and product registration activities.
- Demonstrated expert knowledge of regulatory submission including NDA, IND, IDE, MAA, CTA, CTD, NDS, CTN, JNDA, ACTD submissions and technological advancement on global authority guidelines & current regulations in drugs, medical devices and combination products.
- Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external customer groups.
- Knowledgeable in CTD/eCTD structure and requirements and US submissions (e.g. IND, DMF, NDA, PSUR etc.), a solid understanding of international submission requirements for multiple-countries in all applicable global regions such as Europe, Asia Pacific and other regulatory authorities.
- Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and viewing tools.
- Able to travel domestically and International with little notice