Global Regulatory Affairs Manager, Pharma Strategy Job at Life Science Talent (Stockholm)

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Sr. VP, Head of Regulatory

Join Enveda as a Sr. VP, Head of Regulatory in a remote capacity and help us tra...

Location

United States

Salary:

450000.00 - 480000.00 USD / Year

Enveda

Expiration Date

Until further notice

Requirements

Advanced degree (PhD, PharmD, MSc, or JD) in life sciences or regulatory sciences
15+ years of global regulatory affairs experience in biotech/pharma, including successful submissions
Experience leading regulatory strategy for first-in-class or novel MOA products
Strong written and verbal communication skills with the ability to represent the company with regulators and external partners

Job Responsibility

Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages
Build and manage a high-performing regulatory team across strategy, operations, and publishing

What we offer

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

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

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...

Location

United States , Franklin Lakes

Salary:

59.00 - 63.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
Medical device and international registration experience is a must
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
Strong project management and communication (verbal, written) and skills
Able to independently handle multiple tasks/projects with minimum supervision
Self-starter with the ability to take over responsibilities
Team player, Attention to details, Highly result-oriented
Flexible and reliable personality
ability to manage stressful situations
High personal integrity and ethical standards

Job Responsibility

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Identify ways to improve the efficiency of current work process and best practices as necessary.

What we offer

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.

Fulltime

CMC Development Manager

As a CMC Development Manager, you'll take full ownership of CMC (Chemistry, Manu...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

MSc or PhD in Pharmaceutics, Chemistry, Chemical Engineering, Biology, or related field
5+ years of experience in pharmaceutical formulation, process development, or CMC project management
Deep understanding of API characteristics, QbD principles, and GMP/ICH standards
Proven ability to lead cross-functional CMC workstreams and manage external partners (CMOs/CDMOs)
Strong experience in global regulatory submissions (EU
US is a plus)
Excellent technical writing, communication, and stakeholder management skills
Experience in lean or virtual pharma models and post-approval lifecycle management preferred
Curious, proactive, and collaborative - able to thrive in an agile, fast-moving international environment

Job Responsibility

Lead the end-to-end execution of CMC projects for topical and oral solid dosage forms — from formulation and process design to scale-up and lifecycle management
Translate API properties into formulation and process design criteria
Develop, optimize, and troubleshoot robust formulations and manufacturing processes
Oversee scale-up, validation, and tech transfer activities with CMOs and CDMOs
Author and review CMC documentation including development reports, process descriptions, and validation summaries
Own and ensure scientific integrity of CTD Module 3 content, supporting global submissions and lifecycle variations
Partner with Regulatory Affairs to define submission strategies, timelines, and responses
Drive cross-functional alignment with QA, RA, Supply Chain, and CMOs to ensure timely and compliant CMC delivery
Manage CMC project plans, risk registers, and key milestones for assigned product portfolios

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Value, Access & Pricing Manager

The Value & Access Manager will drive market access strategies and pricing gover...

Location

Egypt , Cairo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BSc. Pharmacy degree with 5+ years of experience in Pharma market with 2 years’ experience in Value & Access roles
Proven pricing background and familiarity with reimbursement systems
Strong understanding of Egypt’s healthcare policy and payer landscape
Previous successful development and implementation of a business plan and/or programs
Analytical ability for pricing and access metrics
Strong leadership skills considering the importance of cross-functional alignment & collaboration
Solid communication and presentation skills
Good organizational, planning, prioritization and time management skills

Job Responsibility

Understand key policy issues in Egypt that impact business continuity
Maximize access for Amgen portfolio based on payer responsibility in targeted sectors/accounts through highlighting the value of Amgen portfolio
Map decision-making processes and engage key stakeholders (payers, HTA bodies, government)
Develop access strategies aligned with affiliate and regional priorities
Develop, implement, and monitor an action plan for priority sectors/accounts in cooperation with the cross-functional team
Ensure net sales objectives in the allocated sectors/accounts
Develop long-term business relationships with identified stakeholders
Ensure launch readiness plans are in place from value & access perspective driving the introduction/access of new launches
Define and execute pricing policies for all accounts in compliance with Amgen’s global SOPs
Monitor pricing trends and competitive dynamics

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Reasonable accommodation for individuals with disabilities

Senior Regulatory Affairs and Quality Assurance Professional

In this role, you'll dive into a dynamic industry that actively collaborates acr...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

You are driven by the same purpose as us and want to contribute to improving the lives of patients around the world
You have a positive and curious mindset
You understand how to balance quality and pragmatism to ensure the best possible outcome for a given project
You are looking for a fun, friendly, and tolerant working environment in a purpose-driven company where your opinion matters
You have +5 years of experience working with quality assurance in the life science industry
You are interested in learning and have some knowledge within regulatory affairs
You pose a strong understanding and experience with design control, qualification and classification of medical devices, technical documentation and supporting project members in the principles of quality assurance
Strong knowledge or working experience with standards and regulations such as ISO 13485, ISO 9001, IEC 62304, GxP and/or CSV
Strong knowledge or working experience with quality principles such as testing, bug management, and risk-based approach in quality
You have a relevant educational background, e.g. biomedical engineering, software engineering or other relevant areas of science or engineering

Job Responsibility

Drive the regulatory strategy for digital health projects to enable global market launch
Support the development team in quality deliverables and activities according to our internal procedures based on IEC 62304 and ISO 27001
Ensure the quality of health software by adherence to the quality management system
Support and review safety risk management & cybersecurity deliverables
Provide regulatory and quality consultancy within development projects
Communicate with pharma-clients to align on issue resolution and deliverables
Participate in client audits
Using and shaping how to use AI tools in daily work

What we offer

A portfolio of meaningful products that impact patient lives at scale
Autonomy, trust, and support to do the best work of your career
An open, collaborative environment with talented peers across engineering, design, clinical, and regulatory
Career growth in one of the leading digital health scale-ups, alongside world-class pharma partners
The opportunity to leave your mark on the future of digital health
Copenhagen’s best view and best office espresso machine

Fulltime

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Global Regulatory Affairs Manager, Pharma Strategy

Job Responsibility

Requirements

What we offer

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