Manager, Early Development Regulatory Lead Job at Alfasigma (Bologna)

Global Trial Manager - Early Development

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and deliverables

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Global Development Product Lead

Leads multiple cross functional oncology product teams from pre-clinical candida...

Location

United States , La Jolla; Cambridge; Bothell; South San Francisco; New York City

Salary:

295900.00 - 478800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

MD or MD-PhD with 10+ years of industry experience in oncology drug development is preferred, track record in oncology clinical research including early phase drug development
Clinical oncology experience: Board certification in oncology preferred
Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development
Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills
Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
Capacity to adapt to a fast-paced and changing environment
Demonstrated history of effective leadership
including cross functional and matrixed teams, managing direct reports when applicable, and experience in seeking and maintaining alignment with cross-functional leaders

Job Responsibility

Leads multiple (~2-4) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages
In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation
Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community
Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To ensure the cross-functional components of the product plans including clinical expertise are provided to project teams, including medical monitoring of clinical trials
Substantial support of CDP development and diligence for external innovation activities
Lead key enterprise level cross-functional workstreams to accelerate R&D decision making
Lead, develop and execute strategic development for early development assets
Ensure timely execution and delivery of product milestones within budget
Communicate with executive management and governance committees to address program needs and provide recommendations

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Executive Director, Medicine Development Leader

GSK is seeking a highly skilled Executive Director, Medicine Development Leader ...

Location

United States; United Kingdom , Waltham; London; Stevenage; Collegeville

Salary:

242250.00 - 403750.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical and Commercial
Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
Experience building budgets and leading the strategic and budget planning process
Experience the healthcare environment, and access in all major markets

Job Responsibility

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
Work with the functional line Heads supporting RIIRU to select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and Target Medicine Profile (TMP) which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

Head of Public Policy

As Head of Public Policy (UK & Ireland) you will report to the General Manager -...

Location

United Kingdom , London

Salary:

Not provided

Voi Technology

Expiration Date

Until further notice

Requirements

Bachelor degree in Law, Political Science, Public Policy, Business, Economics, Communications or similar
Professional fluency in English
Experience in public affairs within mobility, transport, tech or other policy-driven sectors
Strong understanding of the UK political environment and experience influencing regulatory and political processes
Ability to use data and evidence in policy development and advocacy
Skilled in drafting regulatory positions, consultation responses and policymaker-facing arguments
Experience leading complex cross-functional work with local and central stakeholders
Experience managing direct reports and developing teams
Experience from using AI in a specialised, role specific way, and adapt workflows

Job Responsibility

Developing and implementing the UK policy strategy in collaboration with the UK GM, the local team and other central stakeholders
Leading policy development work by outlining regulatory positions, interpreting new rules and producing clear material to support engagement in the UK and Ireland
Working with Analytics and Product teams to strengthen Voi’s evidence base and advocacy positions
Identifying, monitoring and preparing for tenders across the region, ensuring the right policy positioning
Engage proactively with city and regional authorities to shape upcoming mobility tenders and secure opportunities for participation
Collaborating with Product, Operations, Legal, and Tender team to align regulatory positions and support readiness for upcoming rules
Accountability for our public relations including setting strategic direction with our PR agency
Driving proactive PR to drive media stories to help us achieve our policy and commercial objectives
Owning and developing senior political, technical and administrative relationships across the UK & Ireland, ensuring early insight into regulatory developments
Representing Voi in consultations, conferences and working groups ensuring consistent and professional presentation of Voi’s positions

What we offer

Get “skin in the game” through our employee stock options program

Fulltime

New

Senior Engineering Group Leader - System Engineering

Location

United States , Bedford

Salary:

160000.00 - 190000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Must have a bachelor’s degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or closely related field
Advanced degree is preferred
Must have a proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability (7-10 years experience) (team of 5+ ppl strongly desired)
Strong project engineering/management capability with expertise in Waterfall and Agile methodologies
Proven ability to plan and deliver complex programs (resource allocations, workload balancing, WBS, PI planning) while leading and developing high performing team
Experience leading the development of test strategies, exploratory evaluations, and formal design verification from early concept through submission readiness
Must have experience in design requirements and risk management, with the ability to translate identified and emerging risks into actionable verification strategies and detailed test plans, driving risk mitigation to closure in collaboration with cross-functional teams
Partner with Quality Engineering and Regulatory teams to support audit readiness and contribute to the Design History File (DHF)
Should have experience in estimating and plan verification and validation activities across the development lifecycle
Specify detailed and traceable test cases based on system requirements and risk analysis

Job Responsibility

Reporting to the Functional Manager, responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture
Receives requirements specifications from the Project/Program Managers and prepares specifications to design, develop or integrate technologies required to make a product and its specific derivatives
Responsible for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data and any implementation documents
May act as group leader or lead engineer on a major program, perform independent development, and be responsible for a number of smaller projects
Technical authority that helps guide the decision-making process for Coagulation programs
Credible leader who can influence with strong organizational and prioritization skills with a results-oriented mindset
Leads the definition of the instrument risk and V&V strategy driving alignment across cross-functional teams in R&D
Leads with hands-on approach in the development of design verification plans and authoring protocols that map requirements to objective test methods with defined acceptance criteria
Manages a team responsible for planning and execution of the integration strategy together with Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Coag Analytical, and Reagent Development
Partner with the Project Manager to define the Design Control Schedule and resources (FTE, Instruments, Tools)

What we offer

Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation and sick leave
Performance-based bonus

Fulltime

Director of RA CMC

About company: A pre-IPO biotech

Location

China , Shanghai

Salary:

1000000.00 - 1400000.00 CNY / Year

Randstad

Expiration Date

June 03, 2026

Requirements

Advanced degree (Ph.D. preferred, M.S. required) in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field
Minimum of 10 years of combined experience in CMC development (process, analytical, formulation) and Regulatory Affairs CMC within the pharmaceutical industry
Experience with device-drug combination products is a plus
Proven track record of successfully developing and implementing global CMC regulatory strategies from Phase 1 through approval
Extensive experience authoring CMC sections for major filings (IND/NDA) and leading health authority interactions
Comprehensive knowledge of US, EU, and ICH CMC guidelines
Must understand the scientific and technical nuances of oligonucleotide synthesis, purification, analytics, and stability
Outstanding written and verbal communication skills in English are mandatory
Demonstrated ability to think strategically, anticipate regulatory challenges, and develop innovative solutions
Strong leadership presence with the ability to influence and align cross-functional teams without direct authority

Job Responsibility

Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval
Regulatory Submission Leadership: Serve as the Regulatory CMC Lead for major filings. Author, review, and critically assess high-quality CMC sections for all global regulatory submissions
Health Authority Interactions: Lead the preparation, coordination, and execution of all CMC-focused interactions with global health authorities
Expert Guidance on Complex Products: Act as the in-house subject matter expert on global regulatory CMC requirements for complex oligonucleotide-based products, including device-drug combination products
Strategic Liaison & Collaboration: Serve as the primary regulatory liaison between the CMC department and the broader Regulatory Affairs team

Fulltime

New

Senior Director, Clinical Development, Oncology

Moderna is seeking an experienced oncology drug developer lead Clinical Developm...

Location

United States , Cambridge, Massachusetts; Princeton, New Jersey

Salary:

210900.00 - 379200.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment
Experience in oncology drug development demonstrated by at least 3 years in the biopharmaceutical industry
In exceptional cases, at least 5 years of experience as an early-phase clinical trialist in academia would be considered
Medical oncology and/or hematology fellowship training is preferred
Experience in oncology and/or hematology immunotherapeutics is preferred
Experience in conducting translationally rich oncology and/or hematology clinical trials is highly valued
Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Understanding of the entire drug development process, including clinical and non-clinical study design and execution
Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules

Job Responsibility

Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets
Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP
Generates data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
Establishes expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas as needed
Contributes to and partners with the development of strategic initiatives, such as organizational initiatives within Clinical Development
Plays an active role in the technical and leadership development of Clinical Scientists
Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s)
Leads selected clinical development projects for products/franchise of compounds
Able to lead and influence across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Eligible for an annual discretionary bonus, other incentive compensation, or equity award

Fulltime

Manager, Early Development Regulatory Lead

Alfasigma

Location:
Italy , Bologna

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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