Director, CMC Regulatory Affairs
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Location: Rockville - Remote - Rockville, United States
Date Posted: Sep 11, 2024
Requisition ID: AR1471
Job Type: Full-time
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Description
Our Mission: Changing the trajectory of autoimmune diseases.
Our Vision: Enabling patients to live their fullest life.
We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.
Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.
We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and “We Care” so that patients can take our drugs with confidence.
Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia’s working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:
- Achieve together
- Collaborate
- Explore & build
- Act responsibly
Together, we drive to change the trajectory of autoimmune disease for patients in need.
Overview
This role will report to the head of Global Regulatory Affairs and is responsible for overseeing and directing all 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 and 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.
Primary 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.
Qualifications
- Requires a BS/BA Chemistry or Biology or Pharmaceutical Science, advanced degree and/ or RAC preferred
- 10 years' pharmaceutical drug development experience with 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.
- Ability to work collaborative with cross functional partners
- Knowledge of eCTD elements and structure and regulatory technical writing skills.
- Experience supporting and conducting due diligence activities.
- Computer skills; MS Office, Excel and Adobe Acrobat and statistics programs preferred.
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