Hybrid Regulatory Writer (Manager/Sr. Manager level） bei Angitia incorporated limited

Location:

Guangshou, Guangdong, China

Position Summary:

The Regulatory Writer (Manager/Sr. Manager level) contributes to the vision and goals of Global Regulatory Affairs (GRA) by: 

Providing innovative scientific and regulatory writing and submission expertise for products in development by implementing aligned global regulatory strategies and activities for Angitia’s developmental portfolio and accountable for non-clinical, clinical and safety content in global regulatory documentation. Assuring a productive collaboration with key internal stakeholders, such as research, early and late-stage clinical development, CMC, to ensure successful development, strategic alignment and execution of global regulatory strategies that result in successful applications for Angitia’s product portfolio, from early development to Marketing Authorization (MA). 

In collaboration with GRA colleagues and vendors, supporting the establishment and maintenance of high-quality working relationships with CDE and other global regulatory agencies for Angitia. 

Job responsibilities:

• Prepare regulatory submissions to CDE across a diverse portfolio of product types (small molecule, biologics, combinations), development phases, and scientific disciplines (nonclinical, clinical, general regulatory).
• Lead the authoring and review of medical and regulatory documents with cross-function teams [CDE meeting request and package, IND/NDA modules, Clinical Study Reports, Protocols and non-Clinical study reports, etc.]. Responsible for providing advanced expertise and support to Regulatory Management in the development and preparation of regulatory documents.
• Work closely with team members in identifying and ensuring compliance with requirements for responses to request for information after major submissions to global regulatory authorities (INDs/CTAs, BLAs/NDAs). 
• Partner with submission manager to ensure the accuracy and quality of submission-ready documents in a timely manner, compliance of regulatory submissions to regulatory authorities and execution of regulatory strategies.
• Lead the translation of global medical and regulatory documents into Chinese or proof-read the translated documents from vendors to ensure the accuracy and quality of the contents. 
• Understand, interpret, and share relevant guidance and where needed identify and or summarize other information sources (e.g., scientific literature, study summaries, figures, tables, graphs, health authority minutes).
• Prepare templates, develop writing style guidelines, and facilitate efficient team contributions to provision of requested/relevant data and information. Provide expertise and guidance on document design and principles of good medical writing to the department and product teams.
• Partner with regulatory and external publishers to ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
• Ensure quality of regulatory submission documents that comply with appropriate conventions and meet correct format requirements per relevant ICH and other guidance at all stages of development.

Education & qualifications:

Minimum Requirements – Education and Experience: 

Manager level: 

• Master's degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 3 years writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 

OR 

• Bachelor’s degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 5 years of writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 

Sr. Manager level: 

• Master's degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 5 years writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 

OR  

• Bachelor’s degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 7 years of writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 

Other qualifications: 

• Expertise in interpretation of guidance documents and be able to work independently using materials from previous interactions with healthcare authorities, literature, and clinical documentation (protocols, IB, treatment guidelines) to ensure development of timely, accurate and compliant, responses. 
• Experience in working with collaborative, cross-functional teams with strong sense of team-work, regulatory writing experience for nonclinical, clinical, CMC or pharmacovigilance/safety information.
• Working knowledge of statistical concepts and techniques.
• Excellent written and oral communication skills.
• Language: good reading/writing/oral English skills.
• Documented expertise in summarizing scientific content.
• Demonstrated attention to details and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy (Chinese and English).
• Ability to summarize regulatory guidelines and apply them appropriately and understand and interpret clinical/non-clinical data from different sources.
• Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters. 

About Angitia:

Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.

Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.