At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
The CMC Submissions Lead is responsible for executing operational activities in support of pipeline programs (IMPD/CTA/IND), marketing applications (NDA, MAA, BLA, JNDA), agency requests for information, post- approval changes or compliance updates for gloabal franchises.
The incumbent will be tasked with establishing global submission activities and timelines in partnership with global and cross-functional stakeholders in Process Development and Technical Services, Biologics and Small Molecule Operating Units, Regulatory Affairs and QA and will execute operational activities pertaining to the CMC submissions portfolio ensuring critical issues are addressed and milestones are being met. Adherence to established business processes and standard IT tool usage is expected.
On occasion the lead will be asked to contribute to broader improvement initiatives such as strategy development and process enhancement as well as to solicit feedback, support tool development, assist training roll out, etc.
About the position:
- Execute global planning and tracking for CMC submission activities for the franchise portfolio, ensuring appropriate stakeholder engagement and participation
- Day-to-day management of CMC regulatory submissions
- Develops and maintains strong communication and collaboration with the stakeholders
- Provides guidance for submission eCTD granularity and global CMC submission requirements
- Enables high quality CMC documents through content review and compliance to submission ready standards
- Maintains awareness of current trends in regulatory requirements
- Tracks new and updated applicable global regulatory requirements and proactively provides summaries and recommendations as appropriate
- Monitors submission performance and recommends process improvements, and facilitates implementation of changes, training and tools
- Proficient user of the Shire EDMS system and provides support to end users to ensure effective utilization of the document management system
- Actively contributes to process and system improvements by demonstrating innovation and creative thinking
- Involved in department initiatives to create efficient, transparent and compliant practices
- Supports operational excellence for CMC regulatory submissions
- When needed, appropriate escalation of issues for swift resolution with recommendation
Skills you need
- Bachelor?s degree or advanced degree in chemistry, pharmacy, or any closely related field is highly desirable, alternatively experience in a similar role within the pharmaceutical industry
- Minimum of 3 years of experience in the pharmaceutical industry or a relevant regulatory environment including experience in regulatory submission management
- Proficiency in global CMC regulatory submission requirements for small molecules, biologics, combination or plasma derived products would all be a great asset for the role
- Experience with pharmaceutical product/process development early/late stage, Drug Substance/ Drug Product) highly desireable
- Familiarity with regulatory guidelines (eCTD, CMC development, ICH) and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout the development lifecycle is beneficial
- Knowledge of eCTD Submission Ready standards application is beneficial
- Solid working knowledge of current GMP and ICH guidelines
- Ability to take the initiative, work independently and adhere 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.
- Critical competencies include building authentic relationships, global and cross boundary communication and partnership.
- Ability to effectively present information to management and employees at various levels of the organisation
- Strong team player with problem solving ability, multitasking competencies and the skill to effectively present complex issues in oral and written form
- Strong knowledge of the Windows environment and Windows-based desktop productivity applications including Adobe Acrobat Technology.
- Familiarity with Electronic Document Management systems as well as advanced Microsoft Word capabilities is preferred.
Company Insights https://youtu.be/ly_8oO-iJeU
Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 4,500,- gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.