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Associate Director of Regulatory Affairs (International/Global)
Onsite in Cambridge, MA
6+ Month Contract
University Degree in Science or related discipline. PhD or PharmD degree preferred.
At least 8 years of experience of working in one or more areas in Regulatory Affairs in the biotech or pharmaceutical industry.
Sound knowledge and experience of Regulatory Affairs and associated requirements, plus pharmaceutical industry experience of clinical trial and drug development work with a track record of successful drug development through product approval in the US.
Thorough knowledge of the drug development process.
Experience in interfacing with ex-US and ex-EU Health Agencies.
-Work proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global regulatory filing strategies for client's programs across the portfolio.
-Provide strategic regulatory leadership to project teams in early and late stage clinical development to advise on International filing requirements.
-Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle. This will include orphan designation requests, meeting briefing documents, and International Marketing Authorization Applications.
-Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks.
-Prepare CLIENTS's Global Regulatory and Program Teams for International Marketing
-Authorization Application and lead interactions with global health agencies.
-Coordinate responses to global health agencies questions with strict deadlines.
-Serve as a key liaison within internal departments at client, with CROs and with regulatory program managers at global health agencies.
-Maintain regulatory files in a format consistent with internal requirements.
-Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance
-Supervise and mentor direct reports who will be managing other programs.
-Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills.
-Works well on teams and also able to work effectively on own initiative and prepared to take ownership and responsibility for his/her actions.
-Superior verbal and written communication skills.
-Results focused and able to meet deadlines.
-Experience with leading International regulatory filings, including electronic submissions, e.g., INDs, CTAs, NDAs, MAAs, annual reports, safety reporting, etc.
-Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
-Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
-Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
-Adaptable and self-motivated, able to prioritize effectively with good problem-solving and planning abilities.
-Demonstrate clear alignment with CLIENT Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.
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