Associate Director/Director, Global Regulatory Affairs Strategy

2 weeks ago

Boston, United States Scorpion Therapeutics Full time

Scorpion Therapeutics is seeking an experienced Regulatory Strategist to lead strategic planning and execute regulatory plans of early oncology assets from first-in-human to commercialization. Reporting to the Head of Regulatory Affairs and Quality. Have overall responsibility in creating and harmonizing global clinical trial execution, achieving regulatory milestones by collaborating within the cross-functional teams together with an external partner to achieve expedited regulatory pathways towards approvals and commercialization in the US, EU and Asia Pacific regions.

The role is primarily responsible to develop innovative, robust regulatory strategies and ensure their efficient and effective execution in global clinical trial management and product management will align with target product profile and corporate expectations.

Oversee global regulatory strategy and global regulatory submissions (e.g., setting regulatory milestones, INDs, CTAs, NDAs, MAAs, regulatory designations) in compliance with all applicable global regulatory requirements and alignment with program and corporate goals

Collaborate with research, non-clinical development, CMC and clinical development to develop regulatory strategies and tactical plans across regions that will maximize the value of an asset

Serve as the primary company contact to the FDA and other competent authorities; Foster a strong relationship, partnership, and advocacy with global regulatory authorities

Proactively identify regulatory risks to company’s programs and develop risk mitigation plans and harmonize across regions

Serve as the company subject matter expert on regulatory trends and guidance’s and keeps company apprised of expected changes to the regulatory landscape affecting existing and future regulatory policies, regulations, and standards

Familiarity with medical and scientific subject matter as well as evolving key regional regulatory policies and guidance (e.g., US, EU, Japan, and China).

Provide routine regulatory risk assessment in achieving timely and quality IND/CTA submissions and “approvals” in US and ex-US regions, as well as planning for potential risk mitigations.

Ensure functional regulatory alignment is incorporated into development decision making at the Program Team and reflected in the overall regulatory strategic plan and Integrated Development Plan.

Knowledge of the development of innovative drugs and co-development of in vitro diagnostics for patient selection and eventual commercialization as companion diagnostic.

Assist Program Team establishing key submission timelines (e.g., IND/CTA, milestone meetings) to meet program goals, in collaboration with the RST (regulatory submission team).

Partner with Project Management (PM) to conduct regular RST to achieve regulatory milestones.

Coordinate with RST and PM to ensure company’s positions are accurate and supported by functional expertise in submission dossiers.

Lead timely and efficient query responses from World-Wide (WW) health authorities and negotiate with sound scientific rationale to maintain global protocol harmonization as feasible

Monitor the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly to stay competitive.

Provide regulatory and vender oversight (e.g., 3 rd

party clinical trial management) in managing global clinical trial logistics from initial submission to maintenance activities.

Provide regulatory input and assessment in clinical study protocols to proactively align expectations from WW health authorities.

Leverage strategic skills including the ability to assess and make complex decisions and willingness to defend difficult positions aligned with the Head of Regulatory or designee.

Ensure consistent practices with the highest ethical standards in compliance with internal QMS, GCP, local regulations and laws.

Professional Experience/Qualifications

Minimum of 10 years of biotech/biopharmaceutical with a demonstrated record of drug development from non-clinical to registration

M.S./PharmD/PhD preferred

Broad and deep regulatory agency knowledge and experiences interpreting and guiding applications that met global regulatory requirements with operational excellence; Extensive exposure with multiple regulatory agencies

Extensive experience leading, designing, writing and submission of regulatory filings and handling correspondences (IND/NDA/MAA/CTA/CTR)

Ability to build and maintain effective internal and external relationships, including cross-functional teams, individual contractors, contract research organizations, and other vendors to effectively manage all regulatory related activities

Proven ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams (internally/externally) in the preparation of responses to regulatory information requests/queries

Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on regulatory strategies and support project activities

Strong problem solving, critical thinking and analytical skills, required to make sound recommendations and execute decisions

Great attention to detail; ability to organize, prioritize, delegate and adapt quickly to changing environments and priorities

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