Senior Director, Regulatory Affairs

Conteúdo do emprego

Company Description

We appreciate flexibility at Aurinia. This role is posted as Victoria, BC but as a dispersed organization, we are open to fill this role in our US Rockville, MD location, a remote and/or hybrid capacity.

Our Mission

Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.

In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.

Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.

Job Description

POSITION SUMMARY:

Reporting to the VP Regulatory Affairs, the Senior Director Regulatory Affairs will oversee and direct all global (including U.S.) regulatory support and submissions for early to late-stage development (and commercial) biologics products. Responsible for developing and implementing innovative biologics regulatory strategies and the preparation and submission of high-quality Biologics INDs, IMPDs, CTAs, and original marketing applications (NDAs/MAAs) and subsequent supplements and variations, in close collaboration with in-house CMC, Clinical Development, Clinical Operations, 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. 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

ROLE AND RESPONSIBILITIES:

• Define and oversee the development and implementation of biologics regulatory submission strategy. Identify potential regulatory risks to the strategic/operational plans and propose options to mitigate risks
• Manage completion of biologics submissions (e.g. BLA, INDs, CTAs) 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
• Provide input to global development teams on biologics regulatory strategies to achieve development objectives. Plan, prepare, review components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings
• Liaise with cross-functional clinical, CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product progression
• Interact and lead negotiations and/or milestone meetings with regulatory agencies to resolve issues and proactively support development. Prepare and submit responses to questions.
  

Other Responsibilities As Needed

• Maintain a high-level understanding of global (ICH, FDA, EMA) regulatory requirements (in particular biologics) including those for filing and approval of investigational and commercial products.
• Provides regulatory guidance and support to internal groups such as development, quality and manufacturing
• Provide biologics regulatory support for due diligence activities associated with the assessment of business opportunities as necessary.
• Exercise good judgement in elevating and communicating actual or potential regulatory issues.
  

Qualifications

• Minimum BS/BA Biological Science, advanced degree and/or RAC preferred.
• Minimum 10 - 15 years’ pharmaceutical drug development experience and at least 5 - 7 years’ hands-on recent biologics regulatory experience.
• Minimum of three years in a supervisory/management role.
• Solid working knowledge of US and international biologics regulatory (late stage development and commercialisation of pharmaceuticals) requirements/processes and the ability to apply knowledge both strategically and operationally to development projects and commercial product regulatory issues.
• Strong first-hand experience in development of biologics and small molecule products and preparation of BLAs, NDAs, MAAs, and INDs.
• Evidence of managing successful biologics 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.
• Ability to consistently exhibit Aurinia’s We Care values of creating opportunity, acting responsibly, relentlessly persevering and executing with integrity
  

Additional Information

All candidate information will be kept confidential according to EEO guidelines

Videos To Watch

• https://youtu.be/ItIJTDJQB20
  

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