Primary Functions

• The mission of Hutchison MediPharma (US) Inc. Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline products through approval in US and EU
• In this position, the Regulatory Affairs Scientist-Strategy (Senior Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies
• Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU.

Major Responsibilities and Duties

• Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries;
• Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators;
• Liason with US FDA, EU and other regulatory authorities as assigned;
• Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU;
• Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development;
• Ensure compilation of electronic submissions according to current health authority standards;
• Provide regulatory oversight by developing and implementing SOP’s;
• Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects

Qualifications and Education Requirements

• BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR
• Advanced degree, e.g. PhD, PharmD and 2 years industry experience
• Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals
• NDA or BLA filing experience a plus
• Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines
• Good leadership, organization, problem-solving & communication skills
• Excellent written and oral communication skills
• Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process
• Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus
• Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus
• Knowledge of EU regulatory regulations a plus
• Ability to manage priorities and workflow, managing multiple projects and meeting deadlines
• Acute attention to detail
• Good judgement with the ability to make timely and sound decisions

If interested, please forward your resume to kellier@hutch-med.com.

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Primary Responsibilities

• Provide medical and safety expertise as the Product Safety and Pharmacovigilance representative on the product clinical development team.
• Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA).
• Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, safety management plans, study reports, summary of clinical safety and risk management plans.
• Manage and conduct ongoing safety surveillance on assigned products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary.
• Organize and conduct safety management team meetings for assigned products and be responsible for safety surveillance, signal detection and risk management.
• Coordinate the development of guidelines and ensures the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory safety reporting requirements. 

• Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents and aggregate safety reports, identify and lead updates as required.

• Provide support for medical review of individual case safety reports (ICSRs) for assigned products.
• Collaborate with Chinese counterparts and other functional team members to update them on medical assessment, signal detection and safety risk management practices in the US and international markets
• Identify opportunities and manage continuous improvement initiatives related to safety assessment of pharmacovigilance data from all sources.
• Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management.

QUALIFICATIONS

• Physician (MD or equivalent) with minimum 6 years related experience in clinical safety and pharmacovigilance.
• Experience in the oncology therapeutic area is preferred.
• Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs and global safety regulations are highly preferred.
• Experienced in global regulatory environment and processes, and the ability to integrate safety medical knowledge with regulatory and commercial input.
• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications.
• Experienced in PV documents (DSUR, PSUR, and PBRER etc.) and risk management plans.
• Thorough understanding of US and EU pharmacovigilance regulations, GCP and ICH guidelines.
• Demonstrated knowledge of biostatistics and epidemiology are preferred.
• Good ability to interpret complex clinical data and experimental results.
• Working knowledge of validated drug safety database (preferably ARGUS) and MedDRA.
• Ability to influence, negotiate and communicate with both internal and external stakeholders.
• Excellent English (writing and speaking) and excellent mastery of English medical terminology.

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