Jobbörse
Finde Jobs in deiner Nähe – ob vor Ort, hybrid oder remote.- Ähnliche Jobs zu: Regulatory Affairs Manager CMC
Vice President, Regulatory Affairs, CMC
Madrigal PharmaceuticalsConshohocken
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, li
Senior Manager Regulatory Affairs
Workforce Solutions Virens GlobalNew YorkSenior Manager Regulatory AffairsA well-known large consumer products corporation is hiring for Regulatory Affairs Manager. Responsibilities include:Ensure completion of appropriate documents during t
Director, Regulatory Affairs
Sonoma BiotherapeuticsSouth San FranciscoRegulatory ProfessionalSonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive T-reg therapies cell for autoimmune and degenerative diseases. Usin
Director, Regulatory Affairs
Pelthos TherapeuticsDurhamDirector, Regulatory AffairsThe Director, Regulatory Affairs develops, implements, leads and supports regulatory strategies for assigned projects in collaboration with various cross-functional teams.
Manager, Quality Assurance & Regulatory Affairs
PerkinElmerUnited StatesManager, Quality Assurance & Regulatory AffairsWhen joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribu
Manager, Quality Assurance & Regulatory Affairs
PerkinElmerUnited StatesManager, Quality Assurance & Regulatory AffairsWhen joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribu
Global Regulatory Affairs VP
Sight SciencesMenlo ParkSight Sciences in Menlo Park is seeking a Vice President of Regulatory Affairs to oversee all regulatory matters for both U.S. and international spheres. You will manage regulatory strategy for vital
Vice President, Regulatory Affairs
Rhythm Pharmaceuticals Inc.BostonCompany Overview Rhythm is a global, commercial‑stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop
Vice President, Regulatory Affairs
Revolution MedicinesSan FranciscoRevolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers. The company’s R&D pipeline includes RAS(ON) inhibitors design
Vice President, Regulatory Affairs
Sight SciencesMenlo ParkDescriptionAs Vice President of Regulatory Affairs, you will oversee all facets of the company's Regulatory Affairs, providing oversight for all U.S. and international regulatory matters, including fi
Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs
DendreonSeal BeachWho We Are At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel‑T), was the first FDA‑approved immunotherapy for metas
Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs
SitcancerSeal BeachVice President, Regulatory Affairs, Clinical Operations & Medical Affairs US-CA-Seal BeachJob Summary The Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs is responsible for t
Director of Government & Regulatory Affairs
UT Southwestern Medical CenterDallasDirector of Government & Regulatory RelationsWith over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-
Strategisch adviseur Pricing & Regulatory Affairs
SchipholAmsterdam
Nice to know (you) Wij zoeken een strategisch adviseur Pricing & Regulatory Affairs. Onze afdeling is verantwoordelijk om invulling te geven aan de economische regulering van Schiphol en daarmee de
Regulatory Affairs Associate (entry level)
GrifolsUnited Statestable.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifo
Team Manager Regulatory Affairs (m/w/d)
HARIBO DeutschlandGrafschaft
Bringen Sie Ihre Erfahrung ein – für gemeinsamen, langfristigen Erfolg. Werden Sie jetzt Teil des über 8.500-köpfigen HARIBO-Teams in 26 Ländern. Als Fruchtgummi-Nr. 1 haben wir ein gemeinsames Ziel:
VP, Regulatory, Clinical Ops & Medical Affairs
DendreonSeal BeachDendreon is seeking a Vice President of Regulatory Affairs, Clinical Operations & Medical Affairs in Seal Beach, CA. This role requires strategic leadership to align regulatory strategies with clinica
Regulatory Affairs Mitarbeiter (m/w/d)
HumanOptics Holding AGErlangenAls innovativer und international ausgerichteter Hersteller von Premium-Implantaten für die Augenchirurgie entwickeln, produzieren und vertreiben wir Medizinprodukte, um dem menschlichen Auge die best
Regulatory Affairs / PRRC (m/w/d)
ALPRO MEDICAL GMBHSt. Georgen im SchwarzwaldALPRO MEDICAL zählt seit über 30 Jahren zu den innovativen Firmen im Bereich Infektionskontrolle und zu den weltweit führenden Spezialisten im Bereich Reinigung, Desinfektion und Pflege zahnärztlicher
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemHarlemHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemBlytheHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemNorth AugustaHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Senior Licensing Specialist, Canada Regulatory Affairs-2
GE VernovaMarkham
Job Description Summary The Canada Lead Licensing Specialist, Regulatory Affairs, based in Canada, will complete various technical licensing work scopes in Canada, including new reactor licensing f
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemEvansHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemBelvedereHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Vice President, Regulatory Affairs, CMC
- Conshohocken, Pennsylvania, United States
- Conshohocken, Pennsylvania, United States
Über
Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).
Key Accountabilities Business Operations
Act or assign a regulatory representative for each project team.
Oversee the development and implementation of regulatory submission strategy.
Manage the planning, preparation and technical review of regulatory submissions and ensure submissions are completed to meet required/established timelines.
Collaborate on the development and optimization of product development strategy to be consistent with regulatory requirements.
Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions.
Business Strategy
Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.
Provide regulatory guidance and strategy for life-cycle management planning and development for commercial products.
Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes.
Compliance
Ensure regulatory conformance for commercial products through effective change management.
Fiscal Discipline
Manage budget associated with group activities including submission fees (ex-US), business travel and training.
Due Diligence
Provide regulatory support for due diligence activities associated with the assessment of business opportunities.
Qualifications Education & Experience
+20 years of overall relevant experience.
Graduate degree in a scientific/technical discipline (Ph.D., MS Science or PharmD) with a minimum 12 years pharmaceutical drug development experience and 7 years hands‑on regulatory experience.
Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals.
Basic computer skills (MS Office, Excel and Adobe Acrobat).
Experience supporting and conducting due diligence activities.
Knowledge
Strong knowledge of regulations/guidelines governing pharmaceutical/biologics development is required.
Familiarity/understanding of FDA regulatory processes; experience with ex‑US regulatory authorities/processes is required.
Skills & Abilities
Ability to communicate clearly and concisely with senior management and regulatory authorities.
Ability to multitask in a fast‑paced environment with multiple/changing priorities.
Experience managing multiple headcount and developing/mentoring junior staff.
Ability to effectively delegate tasks and hold others accountable.
Physical Requirements
Occasional business travel.
Compensation and Benefits Madrigal’s total rewards strategy includes base salary, bonus, equity, comprehensive benefits and a 401(k) plan. The base salary range for this position is $315,000 to $386,000 per year. All employees receive equity and are eligible for flexible paid time off, medical, dental, vision and life/disability insurance, as well as optional voluntary benefits such as supplemental life insurance and legal services.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need.
#J-18808-Ljbffr
Sprachkenntnisse
- English
Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.