Regulatory Manager (Medical Writing)

Roche

  • Shanghai
  • Permanent
  • Full-time
  • 1 month ago
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionThis OpportunityBe accountable for developing regulatory documents for submission to regulatory authorities under minimal guidance of line managerApplies scientific writing, data analysis, document and project management expertiseLeads cross-functional teams in content preparation with stakeholder management practicesSupports line manager on functional excellence of regulatory documentation and new technology adoption​Roles and ResponsibilitiesManages the preparation of regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPsActs as a key strategic partner for the cross-functional content contributors, and as a lead author who ensures content requirements are met and lean writing principles are followedPlans and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriateResolves issues, errors, or inconsistencies in data with contributors as appropriateReviews document content for organization, clarity, grammar, scientific standards, consistency of content, data and messaging; resolves issues with cross-functional contributors; and ensures compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/within a clinical dossierLeads the review process, including leading/coordinating adjudication of review comments and incorporating review commentsEnsures that documents are published in collaboration with Submission Team and that the document is approved by the single accountable signatoryObtains and applies knowledge of Roche and regulatory guidelines, procedures and best practices across relevant documentsParticipates as a member of key functional/cross-functional team(s), ensuring that teams adequately plan for document deliverablesActively contributes to best practices and continuous improvement initiatives and projects; represents the team in functional and cross-functional initiatives/projects when requiredActively engage in the exploration of new technology in content generation and reuse.Actively pursues knowledge on regulatory, scientific & medical issues important to drug development, assigned products, and disease/therapeutic areasAct as a mentor to new members/less experienced members of the writing teamKey CompetenciesRegulatory and Drug Development KnowledgeUnderstands global regulations and relevant ICH guidelines; understands China regulatory principles and requirements for submissions of regulatory dossiers to health authoritiesUnderstands the role and the practice of regulatory activities; and key activities in drug development and commercializationUnderstands non-clinical and clinical concepts from a broad range of disciplines and knowledge on regulatory, scientific & medical issues important to drug development, relevant products, and disease/therapeutic areasUnderstands how regulatory documentation strategies fit within the broader global and local business strategy and operationsStakeholder ManagementBuilds effective and enduring relationships internally and externally, and applies effective stakeholder management practicesThoroughly communicates the local needs to assure global partners/stakeholders understandingEstablishes and maintains support from stakeholders and influences stakeholders for best solutionsOperational ExcellenceDemonstrated clear, high-quality scientific writing style in the English languageChange ManagementAccepts change as positive and adapts to changing conditionsDeparts from accepted group norms of thinking and behaving when necessaryDemonstrates agility in changing environmentPeople and LeadershipAddresses and resolves conflict by creating an atmosphere of openness and trustWorks effectively with other people over whom he or she has no direct authorityBe good at promoting an idea or vision and be able to influence without authorityStrong project management and team facilitation skillsAbility to independently analyze and synthesize data, and aptitude or proven ability to guide the work of othersSuperb written and oral communication skillsWho You areEducation/QualificationsB.S. or above in Pharmacy, Medical, Biology or related fieldRelevant working experience:*
6 years’ experience in MNC Pharma company, at least 4 years in medical/regulatory writing
  • independent working
  • capable of bilingual writing is a plus
Language and PC Skills:Chinese (mother-tone level) and English (proficiency level)Computer skill: word, excel, power-pointWho we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.

Roche