Senior Director Director, CMC Regulatory Affairs

South San Francisco, CA - USA

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORICs products.
Provide CMC regulatory support for new and ongoing clinical trials e.g. manage/prepare CMC document packages in support of INDs CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
Work collaboratively with Pharmaceutical Development Drug Substance and 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 etc.).

Qualifications :

BA/BS MS or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
At least 10 years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
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 INDNDA 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 candidates who will work in our South San Francisco location is between $220000-$270000 for the Director level and $250000-$300000 for Senior Director level candidates . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc.

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 characteristics.

Remote Work :

Employment Type :

Full-time

Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORICs products.Provide CMC regulatory support for new and ongoing clinical trials e.g. manage/prepare CMC document packages in support of INDs CTAs and amendments to global regul...

Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORICs products.
Provide CMC regulatory support for new and ongoing clinical trials e.g. manage/prepare CMC document packages in support of INDs CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
Work collaboratively with Pharmaceutical Development Drug Substance and 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 etc.).

Qualifications :

BA/BS MS or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
At least 10 years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
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 INDNDA 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 :

Remote Work :

Employment Type :

Full-time

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

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About Company

ORIC Pharmaceuticals

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more

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