Gm Sci Commercial Cmc Submissions

vor 16 Stunden

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**About** the role**:
**How you will contribute**:

- **Maintain doc plan / timeline**
- Receive TOC aligned with Reg-CMC strategy
- Collaborate with Reg-CMC and Content owners to prioritize and align deliverables
- **
Establish document structure**
- Create vdoc and applicable templates
- **
Support author management**
- Provide support to meetings for kickoff, roundtables, content / data reconciliation, and follow-ups
- Support RTQ process (e.g., Rapid Response Team)
- Maintain content verification / approval workflow
- **
Provide support document management**
- QC, formatting, uploading, filing history, headers / footers, linking, and folder / vdocstructure
- Document legalization, as needed
- **
Support issue resolution and mitigation planning activities**
- **
Manage submission readiness**
- Support content verification and the final quality check
- **
Prepare deliverables for support of submissions**
- Transfer TOCs
- Provide submission ready docs to publishing
- Archive necessary documents

**_
DIMENSIONS AND ASPECTS
- **

**Technical/Functional (Line) Expertise**
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 4+ years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is essential
- Demonstrates attention to detail and problem-solving abilities.
- Exercises appropriate judgement when working with project teams.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.

Excellent written and oral communication skills required.
**Leadership**
- _
Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgement._
- _
Works with authors to develop and manage all activities associated with preparing, reviewing, and publishing CMC submissions for commercial products.**Decision-making and Autonomy**
- Very good prioritization skills to balance key priorities.
- Balance between customer and system requirements.

**Interaction**
- Strong communication skills, both written and verbal.
- Ability to engage and influence a range of personnel, peers, and superiors with a collaborative style.

**Innovation**
- Flexibility to support the department in all critical business needs and organizational objectives.
- Drive and energy to multi-task in a fast-paced environment, with flexibility and strength to navigate through crises.

**Complexity**
- Knowledge of drug development requirements for both biologics, plasma, and chemically synthesized products, as well as devices and combination products for entire commercial product portfolio (30+ global commercial brands)
- Ability to represent CMC Regulatory Submissions as a member of project teams.**What you bring to Takeda**:

- Degree in Pharmaceutics, Chemistry Chemical Engineering, or closely related field is desired.
- Minimum 5 years’ experience in the Pharmaceutical Industry, or relevant Regulatory environment.
- Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout out the development lifecycle is required.

**Skills**:

- Working knowledge of current regulations.
- Knowledge of European and US regulatory requirements for drug products and medical device submissions.
- IT skills.
- Familiarity with CTD format and content of regulatory filings.

Behaviors
- Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements
- Embodies Takedas leadership behaviors, coaches and provides oversight on contractors and ensures adequate resourcing of CMC submissions
- Focusing on the few priorities and provide superior results.
- Elevating capabilities for now and the future.

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our 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**:

- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, n

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