Associate Director CMC Regulatory Affairs
Associate Director CMC Regulatory Affairs
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The position is responsible for leading CMC regulatory activities within Regulatory Affairs department to support all ORICs clinical development programs of oncology products. This position involves working closely with crossfunctional 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 ORICs 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 CMCrelated 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 handson 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 Companys core values policies and all applicable regulations
Qualifications :
- BA/BS MS or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
- 1215 years experience with Bachelors degree or 812 years experience and Masters degree or 58 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 CMCrelated regulatory queries from global health authorities.
- Experience with all phases of pharmaceutical development and related implementation of phaseappropriate 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 USPNF.
- 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 handson 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 fastpaced 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 $200000$235000. Associate director level candidates is between $160000$180000. 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 multistate 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
