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Global Regulatory Strategist

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

Solid scientific background (Ph.D., M.D., PharmD), At least 5 years of relevant regulatory experience.

Key responsabilities:

Advise on regulatory landscape and strategies for product portfolio
Provide regulatory input into development strategy
Champion for resources and collaborate on local requirements
Lead global and international regulatory teams for planning and execution
Represent GRS internationally and on non-product related projects

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities

Scope: Products (GT4 to GT8 and beyond, including initial submissions, major variations) Footprint except US, EU, Japan, China, Canada, Switzerland.
Advise and support Local GRS for assessing regulatory landscape and regulations to optimize our regulatory strategies and submission plans within and across a therapeutic area (TA) product portfolio.
Provide actionable Regulatory Input into Development Strategy to enable timely commercial desirable registrations across the region.
Advise global team on specific local requirements or gaps in clinical program to support local submission and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements).
Champion for countries to obtain needed global and regional resources (e.g., to participate in global trials, to prepare bridging reports, to respond to HA queries).
Strategize with GRT Lead and other core GRT members on the regulatory strategy for NCEs and major variations (e.g. line extensions, new indications, label enhancements) and to foster one regulatory voice.
Interface between Global and Local, the IRLs lead International Regulatory Teams, educate and communicate Project specific information (follow-up, update) to local teams, ensure alignment between registration/submission requirements and development plans, translate global regulatory expectations into local plans and lead the execution of these plans, digest and communicate Global Regulatory plans, including HA engagement plans to countries, digest and communicate results for key clinical trials, obtain aligned regulatory position, Represent and deliver the Global TA position, track the execution of the global submission plan.
IRLs Co lead with GRTLs the development and execution of the Global Regulatory Engagement Plan including CTAs and response to HA queries.
Transversal activities: Represent GRS international on R&D teams on an ad hoc basis to communicate and advocate regional regulatory strategies and plans when agenda is relevant to the international markets.
Primary interface, IRLs collaborate and partner with other International counterparts (Commercial, Medical, Access, HEOR, supply chain, TO) to obtain alignment with the regulatory strategies and submission plans (as applicable).
International support for alliances IRLs participate in external partnership negotiations, execution and implementations, when applicable, to ensure advanced awareness of regulatory risks and seamless integration.
Represent GRS and/or GRS International on specific non-product related projects including regulatory policy.

Requirements

Solid scientific background, Ph.D., M.D., PharmD or equivalent professional experience with at least 5 years of relevant regulatory experience.
Demonstrated ability to break down complex, scientific content into logical components.
Demonstrated ability to facilitate issue resolution.
Demonstrated ability to organize / prioritize tasks.
Understanding of tactical role of GRS in the drug development process.
Understanding of general global regulatory requirements for drugs in development.
Understanding of PD&C process and specific GRS responsibilities / deliverables.
PD&C Decision Points for International.