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Associate Director, Regulatory Publishing and
vor 3 Wochen
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **Associate Director, Regulatory Publishing and Submission Management**. **Here, you will be a vital contributor to our inspiring, bold mission.**
**OBJECTIVES/PURPOSE**:_ _
This key position is part of Global Regulatory Operation (GRO) and reports to the Director, Regulatory Publishing and Submission Management. The Associate Director, Publishing and Submission Management will support both strategic and operational activities:
- Provide project and publishing group leadership, and submission oversight in support of Takeda Pharmaceuticals products.
- Collaborate with submission teams, to plan and execute timely regulatory submissions, primarily in eCTD/NeeS formats, in support of investigational and marketed products
- Own submission plans to develop, track and report on deliverables for major milestone submissions including initial NDA, BLA, NDS, or MAA. Identify potential risks to submission plans and propose risk mitigation strategies.
- Partner with project management and functional areas to develop strategic plans for health authority submissions and interactions.
- Liaises with other functional managers to ensure consistency of departmental approach within the company.
- Effectively forecast and manage project specific resources utilising flexible resourcing, and employing global load sharing as standard business practice
- Recognize the internal and external interdependencies among submission activities that could have an impact to the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.
**ACCOUNTABILITIES**
The Associate Director, Publishing and Submission Management will demonstrate Takeda leadership behaviors to accomplish the following responsibilities that include but are not limited to:
You are a great fit for this opportunity if you are engaged and energized by:
- Assists in building effective relationships with external publishing vendors/contractors and software providers as appropriate to facilitate effective processing of the regulatory submission workload.
- Provides support in assuring adherence to budgets, schedules, work plans and key performance indicators (KPIs).
- Assists in developing and maintaining operational strategies for improving Publishing systems/ processes for the efficient publishing and archiving of regulatory submissions
- Maintains fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
- Contributes to decisions making on administrative and operational matters and ensures the publishing team effectively achieves its objectives.
- Maintains an expert, current knowledge of validated systems.
- Represents the company at relevant industry forums and/or software user groups.
- Collaborates with other departments to identify, investigate, and implement new business opportunities.
- When necessary and appropriate, steps in for or lends assistance to direct and indirect reports to help drive results and achieve objectives.
- Good knowledge of company people management policies and procedures including hiring, performance management, corrective action, and compensation administration
- Good leadership skills including changes management, people development, strategic thinking and influencing
- Ability to manage team resources to ensure attainment of department objectives.
- Advanced knowledge of regulatory publishing and electronic document management systems
- Excellent written and oral communication skills.
- Ability to manage multiple customer interfaces and ensuring customer satisfaction
- Effective skills in delivering/ overseeing/ evolving user facing publishing services
- Ability to manage operational responsibilities across disciplines and multiple regions/countries
**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:
We would be thrilled if you brought the following with you:
- 10 + years of experience in pharmaceutical/biotech industry, with 8+ years of hands-on global regulatory submissions management and publishing experience.
- Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
- At least 6 years managing individual contributors in addition to the ability to lead by influence and work effectively in matrix organizational structures
- Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
- Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
- Experience with supporting and leading successful delivery of projects (p
