Department: Regulatory Operations
Reports to (Title): Director/Sr. Director, Regulatory Operations
The Submissions Operations Associate Director is responsible for providing publishing, technical editing and general submission support to the growing Regulatory Operations team. This person will help to establish the Submission Operation Management Function at BeiGene and help to establish an approach for regulatory submissions.
This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for China and the US. This person will collaborate closely with other Regulatory Operations teams to establish the Regulatory Operations department. This person will manage the Publishing, Technical Editing, and Archiving Functions.
Essential Duties & Responsibilities (Primary):
- As the lead of the Submission Operation Management team, helping to establish the team and the sub functions within BeiGene.
- Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers
- Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions.
- Lead strategic processes and provides strategic value to the overall positioning of the department with BeiGene
- Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services.
- Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for BeiGene regulatory dossiers
- Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications.
- Interacts frequently with other functional areas. Maintains constructive and positive interactions with colleagues.
- Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects.
- Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution.
- Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts.
- Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities.
- Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content.
- Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures.
- Lead the development and management of projects as applicable in support of the Regulatory Operations department.
- Manage and develop junior members of staff.
- Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings.
- Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate.
- Manage vendor relationships including required resources, issue resolution and contract negotiation.
Core Competencies, Knowledge and Skill Requirements:
- Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
- Management experience is preferred.
- Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
- Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required
- Strategic thinking is required, with a focus on process improvement and optimization.
- Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
- Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
- Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
- Familiarity with pharmaceutical development and global Regulatory submissions is required.
- Organized with systematic approach to prioritization
- Process orientated to achieve the business objective
- Ability to learn new technologies quickly
Communication & Interpersonal Skills:
- Ability to communicate technical issues to a non-technical audience.
- Must have excellent verbal, written, extensive organizational and time management skills and a strong attention to detail.
- Experience working in and directing cross-functional teams is highly preferred.
- Resilient profile with the ability to deliver in an ambiguous environment
- Curious with learning agility
Education: 10+ years of relevant experience and a BA or BS or 8+years with Master or above
Experience: A minimum of 10 years in the biotechnology or pharmaceutical industry. Preferred candidates will have experience and knowledge in preparation of INDs, NDAs, amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD and publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions desirable. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.