Director Regulatory Affairs Strategy
Lynkx Staffing LLC
Job Description
Job Description
Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants.
- Lead/support Regulatory Affairs Functional Teams (RAFTs) to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
- Lead developing and creating global / regional regulatory strategies for multiple clinical development projects at all stages (Phase 1 through market authorization).
- Author and / or review regulatory documents for submission to US and/or Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs, MAAs, orphan, etc.)
- Provide leadership and strategic input to the Filing Submission Team and lead other project sub-teams, as assigned.
- Lead the preparation for and conduct of formal meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
- Provide on project teams or management committees regulatory expertise/advice on requirements for pre-clinical, clinical disciplines, as well as companion diagnostics, in support of drug candidates under development.
- Create and maintain Regulatory Strategic Development plans and provide strategic input to global project development plans.
- Identify and escalate potential Regulatory issues to executive management and propose risk evaluations and mitigation strategies.
- Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
- Research regulatory requirements to support submissions or inquires from functional groups.
- Remain current on changes in regulatory requirements and environment and be a resource to function groups for regulatory information.
- Prepare and reviews SOPs / WIs to achieve consistency in regulatory standards and compliance.
- Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with application regulations and at the highest level of ethical standards.
- Ph.D. or PharmD degree
- 5-10 years Regulatory Affairs experience
- Strong experience in Regulatory Strategy
- Must have led or currently leading an NDA or BLA filing
- Must have led or currently leading the strategy and authoring of a study plan, i.e., pediatric study, etc.
- Must have led or currently leading label negotiations
- Must have led the preparation of Briefing Documents for milestone meetings
Vacancy posted 18 days ago
Similar jobs that could be interesting for youBased on the Director Regulatory Affairs Strategy in Princeton, NJ vacancy
$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...SuggestedPermanent employmentFull timeWork at officeWork from home$161.93k - $269.88k
...AI service delivery capabilities. The ideal candidate brings strategy and operations expertise, as well as AI expertise and demonstrable... ...& AssuranceDirectly align with enabling areas (e.g. PPN, Regulatory, Marketing & Comms, Sales Excellence) to ensure the AI Assurance...SuggestedFull timeLocal areaVisa sponsorship- ...companies optimize their commercialization through strategic insight, advanced analytics, and technology. From developing go-to-market strategies and building foundational data analytics infrastructures to leveraging artificial intelligence to improve customer insights and...SuggestedRemote workFlexible hours
Beghou Consulting
Princeton, NJ16 days ago $145.6k - $279.4k
...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for biosimilar development and marketed products. The role serves as the U.S. regulatory lead for assigned biosimilar assets, delivering...SuggestedWork at officeVisa sponsorshipWork visaRelocation packageU023 (FCRS = US023) Sandoz Inc
Princeton, NJ3 days ago$145.6k - $279.4k
...Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz continues to go through an exciting and transformative period as a global leader... ...experience or safety reports. Provides regulatory strategy and guidance to cross‑functional development and project teams...SuggestedWork at officeRemote workRelocation packageFlexible hoursSandoz International GmbH
Princeton, NJ3 days ago$189.7k - $237.1k
...Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in... ...develop and execute global regulatory CMC strategies that support clinical development, marketing... ...Manages the CMC regulatory affairs activities for marketed products and compounds...Full timeWork at officeLocal areaRemote workWorldwideNight shift3 days per week$143.84k - $215.76k
...join us!The Senior Manager, Omnichannel Strategy will serve as the digital strategy lead... ...critical role will report to the Associate Director of Omnichannel Strategy and be expected... ...(Ops, Privacy, Data Science, Regulatory, IT) are accounted early and often, particularly...Full timeFixed term contractWork at office$127k - $155k
...analyses that support pricing, contracting, and market access strategies across Sun Pharma's U.S. innovative medicine portfolio. This role... ...that support strategic business decisions.Reporting to the Director, Business Pricing Strategy & Contract Analytics, this position...Contract workFlexible hours$200k - $300k
...contributions to the company's success. The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development... ...The level for this role could range across Director/Sr. Director/Exec Director based on the...SystImmune Inc.
Princeton, NJ5 days ago$212.5k - $250k
...expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive... ...and visible role in advancing CMC strategy and submissions of developmental, life... ...as assigned. Job Details Job Family R&D Job Function Regulatory Affairs...For contractorsLocal areaTAIHO ONCOLOGY INC
Princeton, NJ1 day ago$173.35k - $210.06k
## Associate Director, Commercial Regulatory AffairsPrinceton - NJ - USFind out how well you match with... ...Director of US Commercial Regulatory Affairs requires the ability to apply complex... ..., risk assessment and mitigation strategies to Commercial Teams, Medical Affairs...Hourly payFull timeTemporary workPart timeFor contractorsFixed term contractSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$166.9k - $298.3k
..., and apply that knowledge, our content strategy must evolve so content remains authoritative... ...responsible AI-powered experiences. As Director, Product Management, Content Strategy &... ...Experience with healthcare, clinical, regulatory, or professional-information content. Experience...Full timeWork at office$161.67k - $195.91k
...pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Associate Director, GTN Strategy and Innovation role provides strategic support to the U.S. business (with a significant amount of gross to net adjustments...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$106.87k - $129.5k
...decision-making, drive operational excellence, and enable the delivery of innovative medicines to patients worldwide. The DQS Strategy & Operations team serves as the operational backbone of the organization, enabling effective governance, execution, communications...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workWorldwideFlexible hours$155.6k - $306.8k
Position Summary Private Equity M&A Strategy & Diligence Manager Our Deloitte Strategy & Transactions team helps guide clients... ...with clients to address a range of critical issues brought on by regulatory changes, competition, globalization, advances in technology,...Odd jobWork experience placementLocal area$189.2k - $372.9k
Position Summary Private Equity M&A Strategy & Diligence Senior ManagerOur Deloitte Strategy & Transactions team helps guide clients... ...clients to address a range of critical issues brought on by regulatory changes, competition, globalization, advances in technology,...Odd jobWork experience placementLocal area$129k - $169k
...ll see the impact of your work on the world. Our Operations & Strategy Team Noom's Operations and Strategy team sits at the... ...~ Strong understanding of the healthcare landscape, including regulatory dynamics, payer/provider relationships, pharmacy supply chain,...Full timeSummer workSummer holidayWork at office2 days per week$198.7k - $391.6k
Position Summary Pricing and Sales Strategy_ Senior Manager, Strategy, Growth, and Transformation Our Deloitte Customer team empowers organizations to build deeper relationships with customers through innovative strategies, advanced analytics, Generative AI, transformative...Local area$72k - $141k
...entrepreneurial team of professionals who provide critical support to the Specialty Underwriting organization focusing on three key areas: strategy, business execution and data-driven analytics.Functions of this role include supporting strategic planning efforts, developing...Full timeWork experience placementWork at officeRemote work$152.7k - $267.3k
...success the Novo Nordisk Way by turning the Company’s business strategy into an actionable workforce strategy. A strategy which captures... ...oversight functions. Relationships Reports to the Director, Benefits Portfolio. Interacts with personnel at all levels of...Contract workTemporary workLocal areaFlexible hoursNight shiftNovo Nordisk
Plainsboro, NJ7 days ago- ...Bristol-Myers Squibb is looking for a Director, Global Medical Affairs for Sjogren’s Disease in Princeton, NJ. This role involves leading the medical strategy and execution for Sjogren’s Disease across global markets, ensuring alignment of medical affairs with commercial...
- ...Data Strategy Manager ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver...Work at officeLocal areaWork from homeWorldwideFlexible hours
ZS Associates
Princeton, NJ3 days ago - Regulatory and Clinical Affairs ManagerPrimary Responsibilities:Regulatory Affairs• Preparation and execution of regulatory submissions, including... ...cybersecurity, and product changes.• Develop regulatory strategies and recommendations for new products and software...
$187k - $327k
About the DepartmentNovo Nordisk’s Market Access and Public Affairs team engages diverse stakeholders across political and healthcare... ...realize your potential?The PositionThe Market Access Trade Strategy Director is part of a team responsible for developing channel...Temporary workLocal areaHome officeFlexible hoursNight shift$137k - $235.75k
...recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...R&D is recruiting for an Associate Director, Regulatory Affairs Labeling Product... ...following: Drive the global labeling strategy, including demonstrating an...Full timeWork experience placementLocal areaImmediate startWorldwide- ...Description Description: ROLE SUMMARY The Executive Director, Medical Strategy is a senior medical leadership role responsible for... ...partnering with Executive Management, Clinical Development, Regulatory Affairs, Commercial, Market Access, Pharmacovigilance, and...For contractors
Zydus Therapeutics Inc.
Pennington, NJ6 days ago - Novo Nordisk in Plainsboro, NJ, seeks a Market Access Trade Strategy Director to lead channel strategy for Trade across specialty and retail pharmacies, ensuring profitable access for current and future products. You will oversee pricing, contracting, value communication...
$187.1k - $327.5k
...us?The PositionDevelops and executes the Supply Chain business strategy, planning and reporting for the distribution to direct downstream... ...manage the Supply Chain business.RelationshipsReports to the Director, US Supply Chain and is in direct contact with industry associations...Interim roleLocal areaFlexible hoursNight shift$178k - $307.05k
...& Johnson Innovative Medicine is recruiting for a Senior Director, Workforce Strategy & Operational Excellence located in Pittsburgh, PA, Horsham... ..., organizational readiness, operational excellence, and regulatory integrity of a ~1,500-person patient-engagement...Full timeLocal areaImmediate startFlexible hours$204k - $244k
...Director, Regulatory Affairs – CMC Rocket Pharma is seeking a Director, Regulatory Affairs – CMC to support the success of our gene therapy programs... ...serving as the global product leader for CMC regulatory strategy. Reporting to the Associate Vice President, Regulatory...Temporary workLocal areaShift workRocket Pharmaceuticals
Cranbury, NJ4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director Regulatory Affairs Strategy. Be the first to apply!
Related searches
- regulatory manager Princeton, NJ
- director global regulatory affairs Princeton, NJ
- manager regulatory affairs Princeton, NJ
- head compliance Princeton, NJ
- compliance manager Princeton, NJ
- compliance director Princeton, NJ
- regulatory affairs director Princeton, NJ
- regulatory & compliance manager Princeton, NJ
- planning director Princeton, NJ
- strategic director Princeton, NJ