Manager, Regulatory Submissions Publishing

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **Manager, Regulatory Submissions Publishing** to be based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.**

**OBJECTIVES**:
**ACCOUNTABILITIES**:

- Plans and manages detailed publishing timelines; provides reporting on publishing status to key stakeholders.
- Proactively escalates publishing concerns, risks and issues that may delay/impact the submission and presents risk mitigation for publishing strategy.
- Collaborates with other functional managers to develop strategies to mitigate risks to timelines and other issues
- Keeps abreast of fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
- When necessary and appropriate, steps in for or lends assistance to individual contributor direct reports to help drive results and achieve objectives.
- Work closely with content providers to produce high quality submission-ready documents that adhere to internal and external electronic submission guidelines
- Ensure submission documents meet the level of technical integrity required for Takeda publishing tools
- Provide authors with formatting assistance as needed, as well as guidance with regards to publishing and referencing processes
- Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions
- Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
- Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- 6 + years of experience in pharmaceutical/biotech industry, with 4+ 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.
- Fully understands regulatory publishing and electronic document management systems
- 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 (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projects
- Understanding of relationship management with demonstrated experience in partnering in large scale situations
- Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.
- Expert at motivating individuals and teams to manage the change aspects of implementing a new, outsourced model.
- Must have proven track record to be able to think critically, strategically, independently and problem solve
- Must have high level of motivation, drive, and demonstration of Takeda’s leadership values
- Excellent written and verbal communication skills
- Top notch interpersonal skills in difficult situations
- Ability to work seamlessly with all levels of personnel
- Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations

**WHAT TAKEDA CAN OFFER YOU**

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future _**to people around the world.

**Empowering Our People to Shine**

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time