ManagerDirector, Techinical Regulatory
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 Position
GENERAL POSITION SUMMARY
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions license renewal and annual registrations. Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Works independently within guidelines and policies receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.
Your Opportunity
You will be responsible for preparation of high quality CMC regulatory documents for the products local/global in accordance with Roche corporate standards and the requirements of applicable health authorities in support of local/global filings and contribute to the timely regulatory approval for the local manufactured products.
You will manage regulatory aspects of change control and ensuring appropriate communication to stakeholders regarding management of technical changes. Provide regulatory support for relevant quality systems such as change control discrepancy management as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.
You will interact with regulatory agencies on defined matter.
You will keep TRL (CTP relevant stakeholders) fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
You will contribute to regulatory excellence by identifying opportunities mitigating risks and supporting continuous improvement.
You will support team leader collaborate with the China technical partners and China Partners in PDR China to facilitate One Regulatory Voice supporting assigned regulatory submissions for IND NDA/BLA major and/or complex variations activities across the product lifecycle portfolio.
Who you are
Education
Masters Degree in life science disciplines is preferred
Experience
3 or more years work experience in the pharmaceutical biotechnology or related industry in CMC Regulatory Quality R&D and Manufacturing or related
Experience on generating technical registration dossier for China/EU/USA is preferred.
Analytical development or MSAT or manufacture process development supply chain experience would be a plus
Filing experience in Regulatory Affairs is a plus
Knowledge/Skills/Competencies
Technical Knowledge
Knowledge of ICH WHO China regulations and guidance. Knowledge of regulations and guidelines of other major markets (e.g. FDA EMA) is a plus
Proficiency with a wide range of data/information (CMC clinical non-clinical)
Where pay transparency applies details are provided based on the primary posting location. For this role the primary location is Beijing. If you are interested in additional locations where the role may be available we will provide the relevant compensation details later in the hiring process.
Who we are
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
