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

Sr. Manager, Medical Affairs-Global Clinical Nutrition

The Sr. Manager, Global Medical Affairs – Clinical Nutrition provides clinical a...

Location

United States

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Healthcare professional with 5+ years of clinical experience
Licensed clinician (PharmD, MD, RD, or other relevant allied health professional)
Prior experience in Medical Affairs within pharmaceutical, biotech, or medical device industry required
Strong understanding of regulatory and quality requirements in product development and lifecycle management
Experience in clinical research, evidence generation, and publications preferred
Exposure to real-world evidence, digital health, or informatics strongly preferred
Knowledge of Baxter Clinical Nutrition products is preferred
Knowledge of Clinical Nutrition and/or hospital-based therapies preferred

Job Responsibility

Contribute to development and execution of global medical strategy aligned with product lifecycle and pipeline priorities
Partner with R&D and upstream marketing to identify unmet clinical needs and drive product innovation
Provide clinical input into early-stage development, including TPPs, endpoints, and differentiation strategy
Support competitive landscape assessments and development of clinical value propositions
Serve as Medical Affairs lead on global product core and exploratory/NPD teams
Deliver high-quality, evidence-based medical and scientific information to internal and external stakeholders
Maintain deep knowledge of medical literature and clinical trends to inform strategy and decision-making
Lead interpretation and communication of scientific data to support alignment and engagement
Develop and support evidence generation strategies, including clinical studies, RWE, publications, and advisory forums
Collaborate cross-functionally to generate clinical and health economic evidence and translate insights into value-based outcomes

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

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 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

Brand and Customer Manager Neurology - DACH Region

This pivotal marketing role within the Northwest Europe cluster will significant...

Location

Switzerland , Lucerne

Salary:

Not provided

Randstad

Expiration Date

August 31, 2026

Requirements

A Bachelor's or Master's degree is required
Comprehensive experience in pharmaceutical product management, including concept development, implementation, and management of marketing and digital activities within a pharma company or agency
Proven expertise in the pharmaceutical markets of the DACH region is required
Knowledge in the field of neurology with a focus on migraine is a significant advantage
Proven ability to lead cross-functional teams and foster collaboration with diverse stakeholders, including Sales, Medical, Regulatory, and external partners
Experience using data to improve customer interaction, including customer journey mapping and segmentation
Strong creative abilities with a passion for understanding customer needs, alongside a drive to experiment with new digital trends and marketing innovations
Outstanding analytical skills to solve complex problems and initiate sustainable change
Comprehensive knowledge of regulatory requirements, including laws, codes, and ethical standards in pharmaceutical marketing, to ensure compliance and integrity across all activities
Flexibility and resilience to thrive in a dynamic, fast-paced environment. Ability to work both independently and collaboratively with an open mindset

Job Responsibility

Marketing Strategy and Execution: Responsible for the development and implementation of campaign-based direct interaction and digital marketing initiatives, taking into account market conditions, customer needs, and competitive dynamics—particularly within the DACH pharma markets. Ensuring compliant campaign conception and execution, as well as fostering synergies between markets
Operational Campaign Implementation: Managing and executing daily marketing campaigns, including agency briefings, alignment of materials, and ensuring timely, high-quality deliverables
Content and Material Management: Creating, reviewing, and adapting marketing materials (e.g., presentations, email campaigns, digital assets) in close alignment with Medical and Regulatory affairs to guarantee full compliance
Campaign Management along the Customer Journey: Operationally managing and optimizing campaigns throughout the customer journey, including targeting, segmentation, approval processes, and monitoring ongoing activities
Neurology Market Expertise: Leveraging deep knowledge in the field of neurology, with a specific focus on migraine, to design targeted marketing strategies and campaigns
Customer-Centric Approach: Utilizing customer insights and behavioral analysis to develop personalized, data-driven campaigns that increase engagement across multiple channels
Cross-Functional Collaboration: Working in close alignment with Sales, Medical, Market Access, and other functions to ensure a consistent and effective market approach
Marketing Automation: Optimizing marketing automation processes across products, customers, and countries to boost efficiency and performance
Budget and Resource Management: Supporting the planning, management, and optimization of marketing budgets to ensure the efficient use of resources
Performance Tracking: Continuous monitoring of relevant KPIs, as well as deriving and implementing short-term optimization measures

Fulltime

Sr Director, Medical Affairs

The Senior Director, UCAN Medical Affairs guides strategic and operational initi...

Location

United States , Deerfield

Salary:

224000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent scientific/clinical doctorate)
10+ years of experience in Medical Affairs, Clinical, or Scientific roles within medical devices, pharmaceuticals, or combination products
Proven leadership of downstream and field-based medical organizations across complex portfolios
Deep understanding of medical governance, compliance, and scientific engagement in regulated environments
Applicants must be authorized to work for any employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Own and complete the downstream Medical Affairs strategy across Infusion Systems, IV Solutions, Clinical Nutrition, and Pharmacy products, aligned to regional and global medical objectives
Convert upstream medical strategy, clinical data, and evidence generation plans into tactical downstream medical plans that support launches, line extensions, lifecycle management, and in-market optimization
Ensure scientific and medical differentiation is clearly articulated and appropriately embedded across customer-facing medical activities
Lead and develop Field Medical teams (e.g., MSLs, clinical specialists) supporting downstream portfolios, ensuring consistent implementation, scientific rigor, and compliant HCP engagement
Coordinate Key Opinion Leader (KOL) strategy, including identification, engagement planning, and insight generation across therapy areas
Guide planning and execution of advisory boards, investigator meetings, educational forums, and non-promotional scientific exchanges
Responsible for scientific communication strategies supporting downstream portfolios, including data dissemination, congress strategy, and educational initiatives
Ensure accurate, balanced, and compliant communication of clinical evidence to internal and external collaborators
Collaborate with Medical Information, Clinical Development, and Global Medical teams to maintain uniformity in scientific narratives
Serve as the senior downstream medical partner to Commercial, Downstream Marketing, Sales, Training, Market Access, and Commercial Operations

What we offer

Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs

Fulltime

Sr Director, Medical Affairs

The Senior Director, UCAN Medical Affairs guides strategic and operational initi...

Location

United States , Deerfield

Salary:

224000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent scientific/clinical doctorate)
10+ years of experience in Medical Affairs, Clinical, or Scientific roles within medical devices, pharmaceuticals, or combination products
Proven leadership of downstream and field-based medical organizations across complex portfolios
Deep understanding of medical governance, compliance, and scientific engagement in regulated environments

Job Responsibility

Own and complete the downstream Medical Affairs strategy across Infusion Systems, IV Solutions, Clinical Nutrition, and Pharmacy products, aligned to regional and global medical objectives
Convert upstream medical strategy, clinical data, and evidence generation plans into tactical downstream medical plans that support launches, line extensions, lifecycle management, and in-market optimization
Ensure scientific and medical differentiation is clearly articulated and appropriately embedded across customer-facing medical activities
Lead and develop Field Medical teams (e.g., MSLs, clinical specialists) supporting downstream portfolios, ensuring consistent implementation, scientific rigor, and compliant HCP engagement
Coordinate Key Opinion Leader (KOL) strategy, including identification, engagement planning, and insight generation across therapy areas
Guide planning and execution of advisory boards, investigator meetings, educational forums, and non-promotional scientific exchanges
Responsible for scientific communication strategies supporting downstream portfolios, including data dissemination, congress strategy, and educational initiatives
Ensure accurate, balanced, and compliant communication of clinical evidence to internal and external collaborators
Collaborate with Medical Information, Clinical Development, and Global Medical teams to maintain uniformity in scientific narratives
Serve as the senior downstream medical partner to Commercial, Downstream Marketing, Sales, Training, Market Access, and Commercial Operations

What we offer

Medical and dental coverage starting on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Design Assurance Engineer

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

Location

United Kingdom , Keele

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a Mechanical, Engineering, life science or equivalent.
5 years design control or other design/research project management in a regulated environment.
Project management skills and an ability to work to tight timelines.
Working knowledge of ISO 13485.
Enthusiastic and motivated to develop a career within design of Medical Devices.
Proficient in the use of Microsoft Office.
Excellent communication skills when liaising at all levels within the company and with external customers.
Experience working in medical devices, pharma, automotive or aerospace manufacturing is desirable.

Job Responsibility

Compilation and maintenance of design documentation for global products across the product lifecycle, from product conception through to retirement in accordance with specified regulatory, quality and business requirements.
Conduct Risk Management activities, including Hazard Analysis and Risk Assessments, ensuring appropriate risk mitigation strategies are implemented throughout the design process and product lifecycle.
Liaise with SMEs (subject matter experts) in the business to ensure all design and development tasks are completed in line with applicable requirements and project timelines.
Liaise with quality, regulatory and technical teams to assess product usability and safety throughout the design and development process, including end user usability testing as required.
Provide support for activities falling under the remit of the Quality, Technical, Research and Regulatory Affairs teams regarding product design, development and technical documentation.
Support internal and external audits, inspections and regulatory assessments, ensuring compliance with applicable regulations and standards.
Where appropriate, be able to stand in for the R&D Design Assurance Manager.

What we offer

Competitive salary and benefits
Opportunities to thrive and grow
Team spirit & engagement
Inclusive global teams

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

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Global Regulatory Affairs Manager, Pharma Strategy

Job Responsibility

Requirements

What we offer

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