Favorites ()

Recent Searches

loading

Director of Regulatory CMC

San Diego, CA

Order: 71633

The Associate Director/Director, Regulatory CMC will be responsible for assuring the CMC regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality. The position will provide support for development and future marketed products including driving the development of innovative CMC strategies and providing direction to research, clinical, and manufacturing technical teams. (Position will be filled at level commensurate with experience)

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

  • As a member of the project teams, provide strategic CMC regulatory leadership support for multiple innovative programs

  • Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, NDAs and MAAs)

  • Primary regulatory representative at internal meetings as well as at meetings with regulatory agencies for CMC related issues

  • Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally for initial INDs/CTAs, marketing registration applications, supplements and variations

  • Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports

  • Responsible for compilation, review, approval and submission of high-quality CMC related sections of INDs/CTAs, including responses to questions from various regulatory authorities, working in collaboration with SME’s in Research, Process Development, Manufacturing, Quality, Global Supply Chain and other business partners. Maintain responsibility for all CMC Regulatory timelines

  • Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation

  • Support interactions with regulatory agencies during inspections

  • Assist in the development and maintenance of Regulatory SOPs

  • Take the initiative to solve problems exercising sound judgment and appropriate flexibility within a dynamic environment

  • Act as an authoritative resource within specialty area to internal and external resources

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

  • Advanced relevant life sciences degree, e.g., MS, PhD.  and at least 10 years strategic regulatory experience and a minimum of 7 years regulatory CMC experience in the biotech/pharmaceutical industry.  (An equivalent combination of experience and education may be considered.)

  • Experience with producing CMC sections from early development to pre- and post approval submissions (e.g., INDs/BLAs/NDAs/MAAs/Annual Reports/IMPDs) and familiarity with eCTD structure and granularity requirements

  • Extensive experience with development of CMC development, process validation, comparability protocols, amendments, and supplements

  • Knowledge of both foreign and domestic regulations pertaining to the development, manufacturing and distribution of investigation and commercial drugs

  • Experience with Orphan Drug Designation, breakthrough therapy, and direct interactions supporting health authority GMP inspections desirable is preferred

  • Experience with electronic document control and management system

  • Ability to work and prioritize several projects at once while balancing multiple and overlapping timelines

  • Ability to write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy

  • Ability to assess workload and suggest prioritization to senior staff

  • Demonstrated abilities in collaboration with others and independent thought

  • Familiarity with statistical analysis

  • Working knowledge of good publication practice

  • Detailed knowledge of GMP, and ICH guidelines and related FDA/EMA guidances on CMC submission elements

  • Excellent written and verbal communication skills with a focus on CMC regulatory writing skills

  • Strong project management skills with ability to manage multiple projects and execute in adherence to timelines

  • Desire to work in a collaborative team setting

  • Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally

  •  

“Insert Opco name” provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.