Director, CMC Regulatory
Reporting Line: Head of Regulatory Affairs
Purpose of Position
The incumbent will oversee and direct all global (including U.S.) CMC regulatory support and submissions for late stage development and commercial products. Responsible for developing and implementing innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections for INDs, IMPDs, CTAs, and original marketing applications (NDAs/MAAs) and subsequent supplements and variations, in close collaboration with in-house Manufacturing and Supply Chain and Quality teams, contract manufacturing organizations, external experts, collaborators, and strategic partners. Liaise with regulatory authorities via written/verbal communication and lead meetings on CMC topics. Maintain a high-level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy.
Roles & Responsibilities:
Management of all CMC regulatory activities for development and commercial projects assigned to Regulatory Affairs:
- Define and oversee the development and implementation of CMC regulatory submission strategy. Identify potential CMC regulatory risks to the strategic/operational plans and propose options to mitigate risks
- Manage the planning, preparation and technical review of CMC regulatory submissions (e.g. Module 3 and QOS) and ensure submissions are completed to meet required/established timelines.
- Provide input to global development teams on CMC regulatory strategies to achieve development objectives. Plan, prepare, review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings
- Liaise with cross-functional CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product progression
- Provides regulatory guidance and support to internal groups such as marketing, quality and manufacturing
- Manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to eCTD regulatory guidelines, styles and processes
- Interact with regulatory authorities to address CMC regulatory strategy, milestone meetings, queries and regulatory actions.
- Maintain a high-level understanding of global (ICH, FDA, EMA) regulatory requirements (in particular CMC) including those for filing and approval of investigational and commercial products.
- Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators. Prepare and submit responses to CMC questions. Support interactions with regulatory agencies during GMP and pre-approval inspections
- Provide CMC regulatory support for due diligence activities associated with the assessment of business opportunities as necessary.
- Effect timely and appropriate regulatory management/strategic guidance of post-approval CMC changes/lifecycle management for commercial products. Evaluate regulatory impact on NDA/MAA and make appropriate submissions (e.g., Annual Report, Supplements, Variations).
- Exercise good judgement in elevating and communicating actual or potential CMC regulatory issues.
- Minimum BS/BA Chemistry or Biology or Pharmaceutical Science, advanced degree preferred
- RAC (asset)
- Minimum 10 years’ pharmaceutical drug development experience and 5-7 years’ hands-on CMC regulatory experience.
- Minimum of three years in a supervisory/management role
- Solid working knowledge of US and international CMC regulatory (late stage development and commercialization of pharmaceuticals) requirements/processes and the ability to apply knowledge both strategically and operationally to development projects and commercial product regulatory issues
- Strong firsthand experience in development of small molecule products and preparation of Module 3 (CMC sections) of NDAs, MAAs, and INDs.
- Evidence of managing successful CMC submissions with FDA/EMA and demonstrated evidence of writing regulatory documents for both development and commercial products
- Knowledge of eCTD elements and structure and regulatory technical writing skills.
- Experience supporting and conducting due diligence activities
- Basic computer skills; MS Office, Excel and Adobe Acrobat (statistics programs an asset).
- Excellent skills in planning, organizing, decision-making, attention to detail and problem-solving
- Excellent communication (verbal, writing and presentation) skills and the ability to work collaboratively
- Ability to effectively delegate tasks and hold others accountable.
- Excellent interpersonal and management skills
- Ability to independently as well as multi-task in a fast-paced atmosphere with multiple/changing priorities.
- Willing to travel, both domestic and internationally up to 20% percent of the time
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