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The Lead of GM Sci CMC Submission Management (CSM) manages the Global CMC Regulatory Submissions for Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes for GMS Division by working closely with Global Mfg Sciences subject matter experts, Quality representatives, and cross-functional stakeholders in Regulatory. The Manager will also support the CSM Lead in Global Manufacturing and Supply (GSM) where R&D deliverables are needed for regulatory submissions.
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 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.
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
Strong communication skills, both written and verbal
Ability to engage and influence a range of personnel, peers, and superiors with a collaborative style
(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
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
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
Ability to assess need, apply experience and develop solutions to complex issues and to determine and/or negotiate the most appropriate course of action in a timely manner
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / Experience
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
Working knowledge of current regulations
Knowledge of European and US regulatory requirements for drug products and medical device submissios
Familiarity with CTD format and content of regulatory filings
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
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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