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

Service Line Lead – NAM Regulatory Development & Sciences

ProductLife Group is a global consulting and outsourcing partner to the life sci...

Location

United States

Salary:

200000.00 - 260000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred
20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization
Proven leadership experience in a consulting, professional services, or matrixed delivery environment
Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks
Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development
Ability to translate regulatory requirements into practical, executable development and submission strategies
Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management
Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.

Job Responsibility

Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line
Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction
Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements
Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations
Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing
Act as senior regulatory SME for complex and high‑impact programs
Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations
Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required
Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions
Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization

Fulltime

Business Development Manager

We are looking for a Business Development Manager – Medical Devices, based in th...

Location

United States , Pittsburgh

Salary:

Not provided

IQ Inc.

Expiration Date

Until further notice

Requirements

5 to 10 years of experience in Business Development, ideally within Medical Devices, Digital Health, or other regulated technology environments
Proven experience selling engineering services or complex technology solutions, rather than off‑the‑shelf products
Solid understanding of regulated medical software development at a business and customer‑dialogue level
Demonstrated expertise in prospecting, outbound sales, and lead generation
A relationship‑driven mindset, comfortable engaging with technical, quality, and senior customer stakeholders
Strong communication and presentation skills, with the ability to translate complex technical topics into clear customer value
Structured, resilient, and self‑driven, with a strong sense of ownership over opportunities and accounts
Willingness to travel within the US and internationally, as required
Eligibility to work in the United States

Job Responsibility

Develop and execute business development activities for the Medical Devices domain in the US, aligned with Critical Software’s broader strategy
Build and maintain a strong, up‑to‑date understanding of the medical devices ecosystem, including OEMs, scale‑ups, technology partners, and regulatory context
Identify, qualify, and progress opportunities where Critical’s safety‑critical and regulated software expertise creates real differentiation
Leverage on inbounds leads and proactively initiate outbound contact with relevant decision‑makers and prospective clients
Build trusted, long‑lasting relationships with key customer stakeholders, from engineering and quality leaders to business and executive decision‑makers
Lead consultative sales cycles end‑to‑end, from early discovery and positioning through proposal development, negotiation, and closure
Work closely with engineering and delivery teams to shape credible, technically grounded value propositions
Contribute to strategic account planning and long‑term account growth initiatives and provide regular updates and forecasts to senior management
Represent Critical Software in customer meetings, industry events, and relevant medical technology forums

Fulltime

Business Development Manager

We are looking for a Business Development Manager – Medical Devices, based in th...

Location

United States , Pittsburgh

Salary:

Not provided

IQ Inc.

Expiration Date

Until further notice

Requirements

5 to 10 years of experience in Business Development, ideally within Medical Devices, Digital Health, or other regulated technology environments
Proven experience selling engineering services or complex technology solutions, rather than off‑the‑shelf products
Solid understanding of regulated medical software development at a business and customer‑dialogue level
Demonstrated expertise in prospecting, outbound sales, and lead generation
A relationship‑driven mindset, comfortable engaging with technical, quality, and senior customer stakeholders
Strong communication and presentation skills, with the ability to translate complex technical topics into clear customer value
Structured, resilient, and self‑driven, with a strong sense of ownership over opportunities and accounts
Willingness to travel within the US and internationally, as required

Job Responsibility

Develop and execute business development activities for the Medical Devices domain in the US, aligned with Critical Software’s broader strategy
Build and maintain a strong, up‑to‑date understanding of the medical devices ecosystem, including OEMs, scale‑ups, technology partners, and regulatory context
Identify, qualify, and progress opportunities where Critical’s safety‑critical and regulated software expertise creates real differentiation
Leverage on inbounds leads and proactively initiate outbound contact with relevant decision‑makers and prospective clients
Build trusted, long‑lasting relationships with key customer stakeholders, from engineering and quality leaders to business and executive decision‑makers
Lead consultative sales cycles end‑to‑end, from early discovery and positioning through proposal development, negotiation, and closure
Work closely with engineering and delivery teams to shape credible, technically grounded value propositions
Contribute to strategic account planning and long‑term account growth initiatives and provide regular updates and forecasts to senior management
Represent Critical Software in customer meetings, industry events, and relevant medical technology forums

Senior Liquid Development Manager

An exciting opportunity has arisen to join a globally recognised premium drinks ...

Location

United Kingdom , London

Salary:

Not provided

The People Co.

Expiration Date

Until further notice

Requirements

Degree-qualified (or equivalent) in Food Science, Chemistry or a related scientific discipline
8+ years’ experience within beverage or liquid development in an FMCG environment
Strong technical expertise in formulation, ingredients and processing
Proven experience scaling products from bench to factory
Confident leading full production trials and resolving technical challenges
Skilled in sensory evaluation and flavour assessment
Detail-oriented with excellent documentation and compliance standards
Experienced in cross-functional project leadership
Proactive, solutions-focused and commercially aware
Must have the right to work in the UK

Job Responsibility

Lead the end-to-end delivery of global liquid development projects as part of a cross-functional team
Formulate and optimise beverage products, managing scale-up from laboratory through to full production
Plan and lead factory trials, troubleshooting on-line issues where required
Ensure all formulations meet regulatory and internal quality standards
Own and manage technical documentation including specifications, formulations and manufacturing instructions
Oversee and support sensory evaluation programmes, including flavour profiling and panel training
Collaborate closely with Innovation to define technical feasibility during early-stage scoping
Drive process improvements to enhance efficiency within the liquid development function
Manage supplier relationships to support quality, innovation and on-time delivery
Support co-packer scoping and commissioning where required

What we offer

bonus & package

Fulltime

Market Development Manager - Taste & Flavour Solutions

Help reshape the future of taste. Do you want to work at one of Europe’s leading...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Experience in food ingredients, flavours, or technical B2B sales
A strong ability to sell solutions rather than products
Commercial drive, structure, and execution power
Confidence working with stakeholders across R&D, procurement, marketing, and leadership
A self-starting mindset and comfort operating in a fast-moving startup environment
Willingness to travel across Europe as needed

Job Responsibility

Own and grow key accounts within your industry segment, from early dialogue to long-term partnerships
Drive new business development, identifying new customers, applications, and opportunities across Europe
Act as a trusted commercial partner, translating customer challenges (taste, cost, label, reformulation) into REDUCED solutions
Lead commercial negotiations, including pricing, contracts, and distributor agreements
Work closely with R&D, applications, and regulatory teams to bring concepts and prototypes to life
Build and manage a healthy sales pipeline, forecasts, and commercial KPIs
Represent REDUCED externally at customer meetings, innovation days, and industry events
Bring market, customer, and competitive insights back into our innovation and portfolio strategy

What we offer

A mission-driven company with real impact on the future of food
A validated, differentiated product portfolio with strong customer traction
Backing from top-tier investors and a clear growth trajectory
Direct exposure to leadership and a high degree of ownership
A talented, ambitious, and down-to-earth team

Fulltime

Business Development Manager - South East Asia

Biocomposites is an international medical devices company that engineers, manufa...

Location

Philippines , Manila

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Background in orthopaedics, woundcare or medical devices
Willing to take ownership of their region and formulate a clear business plan
Ability to influence and persuade key HCPs (surgeons, clinical microbiologists, procurement etc.)
Naturally inquisitive, eager to learn and highly self-motivated
Comfortable presenting to groups of clinicians as well as supporting the use of the product in an operating theatre environment
Demonstrate strong organisational and time management skills
Exhibit excellent problem-solving abilities and adaptability in dynamic environments
Maintain a results-driven attitude with a focus on meeting or exceeding goals
Exhibit strong interpersonal skills, fostering productive relationships with clients and colleagues
Work both independently and as part of a collaborative team

Job Responsibility

Manage and lead your region to drive adoption, improve patient outcomes and meet sales objectives
Train and support existing key sales channels in The Philippines, Taiwan, Hong Kong, Taiwan, Korea
Identifying and converting new accounts across the specialities whilst at the same time supporting existing accounts in order to achieve regional sales objectives
Build early clinical adoption through education and KOL engagement
Establishment of wound care excellence centres
Develop an understanding of the market unique to assigned territory
Develop relationships in all areas of the hospital that are key to Biocomposites
To become a subject matter expert, with an excellent understanding of infection and related issues
To identify strategic accounts and future clinical advocates
To work with the marketing and clinical & technical research team to define product positioning and develop marketing materials

What we offer

Competitive salary and benefits
Opportunities to thrive and grow
Stimulating and varied workplace in an innovative, passionate and performance-oriented team
Engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions

Lead Project Manager

In a challenging and multicultural environment, we seek a senior lead project ma...

Location

Singapore , Singapour

Salary:

Not provided

Crédit Agricole

Expiration Date

Until further notice

Requirements

Minimum of 8 years of relevant experiences, ideally in a CIB banking environment
Leadership
Excellent team management skills
Strong ability to understand the big picture
Ability to drill down complex issues to simple comprehensible terms
Demonstrated skill to work across functions, regions and cultures
Excellent problem solving and conflict resolution skillset
Strong communication with wide variety of individuals at all executive levels
Ability to Influence and motivate
Expertise in project cycle management and methodology

Job Responsibility

Manage the list of CIB IT projects, collaborating with leadership across the departments and prioritize projects based on the business need
Direct the work of Project managers and provides managerial oversight for multiple projects
Act as point of escalation for the Project management team
Create and develop a governance structure for efficient stakeholder management
Promote the project management service
Develops organizational project management capabilities through training, coaching, and individual meetings/discussions
Develop strategy for control and governance structures to ensure desired outcomes across the projects
Monitor and analyse project metrics and to propose improvements and cost savings for future projects
Ensure successful delivery of all projects against cost, time, scope, quality and security measures
Operate autonomously and handle large scale APAC/EMEA regional IT projects by understanding local regulations

Fulltime

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

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Manager, Early Development Regulatory Lead

Job Description

Job Responsibility

Requirements

What we offer

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