Associate Director, CMC Regulatory Affairs

1 month ago

San Mateo CA, United States Mirum Pharmaceuticals Inc Full time

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it's like to be a part of our team:

POSTION SUMMARY

Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls). This role will assist with global clinical trial applications, global marketing applications (including US, Europe, Canada, Rest of World, etc.), and global post approval CMC activities. The position will be responsible for CMC-related submission planning and for ensuring that high?quality and accurate submission documents are provided within agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss data within cross-functional teams and with health authorities.

JOB FUNCTIONS/RESPONSIBILITIES

* Leads and support the development and implementation of CMC regulatory strategy to support global development programs and market applications.

* Responsible for ensuring the appropriate execution of CMC regulatory strategy.

* Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.

* Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams).

* Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.

* Support the preparation of risk assessments on CMC regulatory topics.

* Ensure CMC dossiers meet ICH requirements, as well as country specific requirements.

* Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC.

* Support authoring of meeting requests, briefing documents, responses to health authority inquiries, IND/IMPD amendments, post approval changes, and relevant annual updates.

* Review clinical trial label content against country specific requirements.

* Lead or support Health Authority interactions.

* Manage and maintain regulatory CMC tracker and documents.

* Complete other responsibilities as assigned and/or agreed upon.

QUALIFICATIONS

Education/Experience:

* Minimum 8 years of relevant experience in CMC Regulatory Affairs.

* Experience in drug development, market applications and commercial lifecycle.

* Work experience in Regulatory Affairs or related discipline.

* Experience with small molecule regulatory CMC preferred.

* Understanding of multiple drug product dosing forms preferred.

* Experience in preparing CTAs, INDs, , IMPDs, NDAs, MAAs, and Rest of World filings. Knowledgeable of GCP, GXP requirements, ICH, and FDA/EMA guidelines.

* Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.

* Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.

* Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

* Demonstrate ability to manage priorities, multi-task and follow projects through to completion.

Knowledge, Skills and Abilities:

* Use of collaborative workspace (BOX, SharePoint, Veeva, Microsoft Professionals, Adobe, etc.)

* Familiar with navigating to global regulatory websites (ICH, FDA, EMA, etc.)

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

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