Cmc Submission Lead

**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.

**About** the role**:
Under the direction of the CMC Submissions line manager, the CMC Submissions Manager (CSM) is responsible for execution of global CMC Regulatory Submissions operational activities and Project Management in support of pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, Post
- Approval changes, etc.

**How you will contribute**:
**Regulatory Submissions Management**
- Planning and tracking for CMC submission activities for the assigned product/project, ensuring appropriate stakeholder engagement and participation.- Day-to-day management of CMC regulatory submissions, including preparation for and leading of meetings, document manipulation and routing for authoring and review, etc.
- Provide guidance for submission eCTD granularity and global CMC submission requirements.
- Enable high quality CMC documents through content review and compliance to submission ready standards
- Develop and maintains strong communication and collaboration with the stakeholders.
- Be proficient on the Electronic Document Management System (EDMS) system and provides support to end users to ensure effective utilization of document management systems.

**What you bring to Takeda**:

- Bachelor’s degree or advanced degree in Chemistry, Pharmacy, or closely related field is highly desirable.
- Minimum 5 years’ experience in the Pharmaceutical Industry or relevant Regulatory environment including experience in CMC and regulatory submission management.
- Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout the development lifecycle desired.

**Key Skills, Abilities, and Competencies**
- Solid working knowledge of current GMP and ICH guidelines and regulatory requirements.
- Knowledge of drug development for drug substance and drug product.
- Project Management skills.
- Ability to take the initiative, work independently, and complete tasks to deadlines
- Requires very strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
- Requires excellent interpersonal, diplomatic communication, analytical, and organisational skills.
- Ability to effectively present information to management and employees at various levels of the organisation.
- Appropriately escalates issues for swift resolution with recommendation-
- Critical competencies: building authentic relationships, global and cross boundary communication and partnership.
- Strong team player.

**Complexity and Problem Solving**
- Requires problem solving ability, multitasking and the skill to present complex issues in oral and written form.
- Understanding of objectives and processes across multi-disciplinary functions involved in drug development, registration compliance and quality (GxPs).

**Internal and External Contacts**
- Liaises with multiple cross-functional teams within Takeda and external Takeda partners.

**Other Job Requirements**
- Ability to participate in occasional early or late meetings/teleconferences.
- Working hour’s flexibility to meet submission deadlines.

**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, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law._

**Locations**:
Zurich, Switzerland

Boston, MA
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time