Associate Director, CMC Regulatory Affairs
Description
The 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.
Qualifications & Experience:
- 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.
The anticipated salary range for director level candidates is between $200,000-$235,000 and 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.