Associate Director, CMC Regulatory Affairs
4 days ago
ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatment-resistant cancers. Our culture and values support our mission, provide a shared understanding of how we work together as a company and provide a clear sense of what is most important to us as an organization.
Job DescriptionThe position is responsible for leading CMC regulatory activities within Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products. This position involves working closely with cross-functional colleagues including regulatory operations, quality, CMC, nonclinical and clinical team members. S/he will be a highly motivated team player with the ability to plan proactively, work independently, think strategically and execute assigned projects effectively.
Responsibilities:
- Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC’s products.
- Provide CMC regulatory support for new and ongoing clinical trials, eg, manage/prepare IMPD, CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
- Work collaboratively with Pharmaceutical Science for drug substance and drug product development, GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
- Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
- Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
- Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs, etc.
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
- Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, QOS, and etc.).
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
- BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
- 12-15 years experience with Bachelor's degree -or- 8-12 years experience and Master's degree -or- 5-8 years experience and PhD.
- Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid- oral dose formulations, manufacturing, and regulatory writing.
- Experience in addressing CMC-related regulatory queries from global health authorities.
- Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
- Demonstrated success driving drug product development and managing all aspects of CMC documentation.
- Excellent working knowledge and understanding of applicable global regulations required – cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
- Prior experience as primary author of CMC sections of M2 and M3 of IND and NDA, and IMPD.
- Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
- Excellent attention to detail, and strong computer and organizational skills required.
- Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
- Must have a quality mindset and deliver results in an ethical and positive manner.
- Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
- Proven ability to manage multiple tasks and associated deadlines.
Additional Information
The anticipated salary range for director level candidates is between $200,000-$235,000. Associate director level candidates is between $160,000-$180,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC is a multi-state employee, and this salary range may not reflect positions that work in other states.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.
-
Director of Regulatory Affairs CMC
7 days ago
San Diego, California, United States ORIC Pharmaceuticals Full timeJob DescriptionThe Associate Director, CMC Regulatory Affairs role is a highly sought-after position at ORIC Pharmaceuticals, where you will lead CMC regulatory activities within the Regulatory Affairs department. Your primary objective will be to support all clinical development programs of oncology products.
-
Associate Director, CMC Regulatory Affairs
4 days ago
San Diego, United States ORIC Pharmaceuticals, Inc. Full timeAssociate Director, CMC Regulatory AffairsFull-timeDepartment: Regulatory/QAORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for...
-
Associate Director, CMC Regulatory Affairs
4 days ago
San Diego, United States ORIC Pharmaceuticals, Inc. Full timeThe position is responsible for leading CMC regulatory activities within Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products. This position involves working closely with cross-functional colleagues including regulatory operations, quality, CMC, nonclinical and clinical team members. S/he will be a highly...
-
Associate Director, Regulatory Affairs CMC
4 days ago
San Francisco, United States Tbwa ChiatDay Inc Full timeAssociate Director, Regulatory Affairs CMC Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families...
-
Senior Director, CMC Regulatory Affairs
4 days ago
San Francisco, United States Tbwa ChiatDay Inc Full timeVir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple...
-
Regulatory Affairs Director
7 days ago
San Diego, California, United States Ignite Human Capital Full timeJob Summary:We are seeking a seasoned Regulatory Affairs Director to lead our cell therapy regulatory strategy and activities. This pivotal role will spearhead regulatory planning, agency interactions, and submissions.About Us:Ignite Human Capital is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and...
-
Senior Director, CMC Regulatory Affairs
4 days ago
San Francisco, United States Tbwa ChiatDay Inc Full timeVir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple...
-
Sr. Director, Regulatory Affairs
7 days ago
South San Francisco, United States Structure Therapeutics Full timeJob DescriptionJob DescriptionSalary: Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available,...
-
Regulatory Affairs Expert for CMC Compliance
5 days ago
San Rafael, California, United States Meet Full timeOverviewThe Senior Manager, CMC Regulatory role plays a pivotal part in the company's regulatory strategy. This individual will oversee the planning, preparation, and submission of global regulatory CMC-related content for clinical trial applications, marketing applications, and periodic reports. Key responsibilities include ensuring compliance with relevant...
-
Regulatory Affairs Director
6 days ago
South San Francisco, California, United States Structure Therapeutics Full timeAbout the Role:We are seeking an experienced Regulatory Affairs Director to lead our CMC regulatory strategy globally and manage the required resources to meet an aggressive regulatory submission schedule.Responsibilities:Direct successful preparation and approval of INDs, CTAs, NDA, MAA, and other CMC regulatory submissionsDevelop, compile, maintain, and...
-
San Diego, California, United States ORIC Pharmaceuticals Full timeJob SummaryWe are seeking a talented individual to fill the role of Director of Regulatory Affairs CMC at ORIC Pharmaceuticals. This key position involves developing and implementing effective CMC regulatory strategies, ensuring compliance with global regulatory requirements for the development of our products.
-
CMC Regulatory Lead Director
6 days ago
San Diego, California, United States ORIC Pharmaceuticals Full timeAbout the RoleThis senior leadership position requires an experienced professional with a strong background in small molecules and solid oral dose formulations. As the CMC Regulatory Lead Director, you will oversee all CMC regulatory strategies and collaborate closely with cross-functional colleagues, including regulatory operations, quality, CMC,...
-
San Francisco, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
San Francisco, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
San Diego, United States Janux Therapeutics Full timeThe Associate Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support the global development and expansion of Janux’s clinical pipeline. This individual will work closely with cross-functional teams to ensure compliance with regulatory requirements and to achieve successful regulatory...
-
Director of Regulatory Affairs
6 days ago
San Diego, United States Avetix Group Full timeExperience with Immunology, Dermatology or Inflammation is a must.Duties & Responsibilities • Develop and execute global regulatory strategies to support the discovery, development, and registration of all company portfolio products for major markets such as the US. • Lead global strategic and operational planning, management, support and execution of...
-
Director of Regulatory Affairs
6 days ago
San Diego, United States Avetix Group Full timeExperience with Immunology, Dermatology or Inflammation is a must.Duties & Responsibilities • Develop and execute global regulatory strategies to support the discovery, development, and registration of all company portfolio products for major markets such as the US. • Lead global strategic and operational planning, management, support and execution of...
-
Global Regulatory Affairs Director
7 days ago
South San Francisco, California, United States Alumis Full timeRole SummaryThis role will report to the Executive Director and Head of Regulatory Strategy, providing organizational support as the company and its product development pipeline grow.Key ResponsibilitiesThe successful candidate will lead regulatory agency interactions, develop and implement regulatory strategies, and serve as the Regulatory Affairs...
-
Regulatory Affairs
1 week ago
San Diego, United States Manpower San Diego Full timeJob Title: Regulatory Affairs – ContractorLocation: RemoteSchedule: Monday – Friday, 8:00 AM – 5:00 PM PSTDuration: 6 monthsPay: $42.00 - $82.00 per hour depending on experienceDo you take pride in the work you do and continuously strive to achieve more? Here, you will make a meaningful impact. We seek talented individuals who are ready to take on...
-
Regulatory Affairs
1 week ago
San Diego, United States Manpower San Diego Full timeJob Title: Regulatory Affairs – ContractorLocation: RemoteSchedule: Monday – Friday, 8:00 AM – 5:00 PM PSTDuration: 6 monthsPay: $42.00 - $82.00 per hour depending on experienceDo you take pride in the work you do and continuously strive to achieve more? Here, you will make a meaningful impact. We seek talented individuals who are ready to take on...
