Senior Director, Regulatory Affairs

Found in: Jooble US O C2 - 2 weeks ago

Boston MA, United States Proclinical Staffing Full time

Senior Director, Regulatory Affairs - Permanent - Remote

Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.

In this role, you will provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology. In addition you will provide strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks.

Relevant science degree & post graduate specialization or equivalent experience in medicinal product development and regulatory strategy.
Strategic regulatory experience in novel oncology investigational product development to registration including interactions with US and European regulatory authorities.
Prior regulatory authority experience desirable.
Typically requires 15-20+ years relevant clinical research and/or regulatory experience with multi-regional and global focus including significant experience in senior strategic role, including specific oncology investigational product experience

The Senior Director, Regulatory Affairs will:
Integrate strategic regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings. Interface with clients in collaboration with existing Therapeutic Science & Strategy Unit Centres of Excellence to provide strategic advice and incorporate regulatory guidance.
Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
Lead assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
Support the innovative development of compounds to maximize technical, regulatory, and commercial success, including contribution to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate.
Strategic leadership of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, "fast-track", "break-through" etc…).
Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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