Regulatory Affairs Manager

Location
San Diego, CA
Posted
Sep 15, 2020
Required Education
Bachelors Degree
Position Type
Full time

About the Company

The Emerald Health Pharmaceuticals Inc. (EHP) vision is to make a significant positive difference in the lives of patients through the development of safe, novel medicines in a wide range of therapeutic indications.  Our strategy is the development of patented new chemical entities (NCEs) derived from cannabinoid-based molecules that affect validated targets for many diseases with unmet medical needs. EHP, a clinical-stage company entering Phase II international studies in autoimmune and fibrotic diseases, is headquartered in San Diego, CA.

EHP was founded in 2017. Since then we have advanced our lead molecule into Phase II clinical studies for the treatment of multiple sclerosis and systemic sclerosis (a form of scleroderma). Our second development program with another NCE is in preclinical development and is targeting Parkinson’s disease and Huntington’s disease.

EHP works closely with Emerald Health Biotechnology España to build on our world-leading position in the field of cannabinoid science and pharmaceutical development. 

About the Role

The Regulatory Manager, reporting to the Senior VP, Regulatory and Quality Affairs, is responsible for various activities related to regulatory affairs, including the preparation and submission of regulatory documents, regulatory correspondence, tracking, filing, and writing regulatory SOPs. 

The successful candidate will work directly with the Senior VP, Regulatory and Quality Affairs and project teams, as well as external vendors as needed, to provide hands-on management of regulatory operations activities. 

He/She will possess sound judgement, excellent interpersonal and problem-solving skills, and a working knowledge of all study-specific synopses, protocols, submissions and other regulatory documents.


Job Responsibilities

·       Assist and help manage regulatory submissions 

·       Provide support in generation of regulatory documents

·       Provide review of documentation supporting regulatory submissions

·       Support regulatory leadership for periodic reports submitted to regulatory agencies

·       Recommend regulatory procedures and practices to assure adherence to regulatory requirements

·       Maintain current awareness of relevant regulatory requirements and identify and assess regulatory risks and mitigation plans and communicates changes in regulatory information to the project team and management team

·       Ensure that all clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

·       Communicate effectively with project teams and functional heads about regulatory paths and requirements

·       Assist with the oversight and management of vendors and consultants

·       Monitor the progress of the regulatory authority review process and support meetings with regulatory agencies

·       Author relevant Standard Operating Procedures (SOPs) and work instructions

·       Use and continually develop leadership skills

·       Attends conferences and training as required to maintain proficiency

·       Performs other related duties as assigned

Requirements

·       Bachelor’s degree in appropriate field of study or equivalent combination of related education and applicable job experience; RAC certification a plus 

·       5 plus years of relevant pharmaceutical/biotechnology experience in Regulatory Affairs in both early and late stage development programs

·       Direct regulatory filing experience (IND/NDA/BLA or equivalent)

·       Experience in a regulated environment (FDA/CLIA preferred)

·       Excellent external and internal communication skills, in particular concise and precise verbal and written communication skills 

·       Excellent writing and editing skills, with attention to details

·       Proficient use of MS Office and other relevant computer software

·       Strong interpersonal skills with team orientation

·       Ability to rely on experience and judgement to plan and accomplish goals.

·       Solid organizational skills including attention to detail and multitasking skills

·       Ability to work in the San Diego office