Associate Director, Regulatory Scientific 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.
#J-18808-Ljbffr

  • Regulatory Affairs CMC Associate

    2 weeks ago

    San Mateo, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

  • Regulatory Affairs Associate

    2 weeks ago

    San Mateo, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting roleResponsible for the preparation of Drug...

  • Regulatory Affairs CMC Associate

    7 days ago

    San Mateo, United States The Fountain Group Full time

    Overview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational...

  • Associate Director Regulatory Affairs

    12 hours ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Associate Director Regulatory Affairs

    5 hours ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Regulatory Affairs Director

    4 weeks ago

    San Francisco, United States BioLink 360 Full time

    Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

  • Director of Regulatory Affairs

    1 month ago

    San Antonio, United States Evestra, Inc. Full time

    Our Company:Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products. Responsibilities:Develop and oversee regulatory...

  • Director of Regulatory Affairs

    4 weeks ago

    San Antonio, United States Evestra, Inc. Full time

    Our Company:Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products. Responsibilities:Develop and oversee regulatory...

  • Director of Regulatory Affairs

    4 weeks ago

    San Antonio, United States Evestra, Inc. Full time

    Our Company:Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products. Responsibilities:Develop and oversee regulatory...

  • Director, Regulatory Affairs

    1 week ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

  • Director, Regulatory Affairs

    2 weeks ago

    South San Francisco, California, United States Maze Therapeutics Full time

    The Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

  • Director, Regulatory Affairs

    2 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...

  • Executive Director, Regulatory Affairs

    1 month ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Executive Director, Regulatory Affairs

    4 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Senior Director Regulatory Affairs

    4 days ago

    San Francisco, United States SciPro Full time

    Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based...

  • Senior Director Regulatory Affairs

    1 month ago

    San Francisco, United States SciPro Full time

    Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based...

  • Director of Regulatory Affairs San Jose, CA REF

    3 days ago

    San Jose, United States ESR Healthcare Full time

    Director of Regulatory Affairs San Jose, CA REF DESCRIPTION The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination...

  • Vice President, Regulatory Affairs

    2 weeks ago

    San Diego, United States Device Search Group Full time

    We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

  • Vice President, Regulatory Affairs

    4 days ago

    San Diego, United States Device Search Group Full time

    We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

  • Regulatory Affairs Specialist

    3 weeks ago

    San Francisco, California, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities:Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration.Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical...