CrawlJobs Logo
Life Science Talent Logo Life Science Talent · Research and Development

Senior Scientific and Regulatory Affairs Expert

Denmark, København · Job Posted March 14, 2026
Apply Position
Job Link Share

Job Description

Bactolife is looking for an experienced scientific and regulatory affairs expert to support the commercialization of Bactolife’s Binding Proteins globally. You will be responsible for the regulatory work in ensuring market access for our functional precision-fermented Binding Protein ingredients in different Asian countries. Joining Bactolife at this stage of growth means working in a dynamic environment where responsibilities will evolve alongside the company. As an expert, you will leverage your professional judgment and subject-matter expertise across strategy, planning, analysis, and operational execution. The role requires flexibility, collaboration, and the ability to contribute at both tactical and operational levels, a mindset shared across the organization as we scale.

Job Responsibility

  • Identify and work with expert consultants from the Asia-Pacific region
  • Prepare food ingredient dossier submission, registration, and renewal strategies for products within the region to gain and maintain market access
  • Support local consultants in engaging with key external stakeholders and local authorities in pre- and post-submission meetings
  • Understand and guide health claim options and substantiation hereof for different consumer product categories such as health/dietary supplements
  • Conduct compliance reviews and provide daily support to the business development team in preparing and executing customer pitches and dialogues
  • Support the regulatory tasks/questions to EU novel food approvals, our business development as well as our clinical research activities

Requirements

  • Collaborative team player with a proven ability to build and maintain strong, long-lasting relationships
  • Result- and solution-oriented, with a genuine interest in supporting business development
  • 10+ years’ experience within Regulatory Affairs or related areas, preferably with vast experience from the food tech and/or consumer health space
  • Experience with precision-fermented/GMM-derived ingredients dossier preparation and approval
  • Good understanding of Novel Food regulations in EU and/or in the Asia-Pacific region
  • Excellent communication skills and the ability to connect with external stakeholders such as expert consultants, customers and authorities
  • Good project management skills and attention to detail
  • MSc or PhD in a relevant field, Biotechnology, Biology, Chemistry, Microbiology, Nutrition or other related scientific disciplines

Nice to have

Experience with claims in labelling and advertising is a plus

Life Science Talent - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Scientific and Regulatory Affairs Expert

8 matching positions

Senior Manager, US Regulatory Affairs and Ingredient Support

COTY is looking for smart leaders who are fast and passionate! We challenge conv...
Location
Location
United States , Morris Plains
Salary
Salary:
110000.00 - 135000.00 USD / Year
coty.com Logo
Coty Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Biology, Chemistry or related scientific field
  • 10 years of experience in Regulatory Affairs
  • Minimum of 3-5 years related experience within the cosmetics industry, personal care industry, or related industry, in Regulatory Affairs
  • Ability to work effectively both independently and as part of a team with diverse groups of people at various levels and geographies
  • Strong oral and written communication skills, especially detail-oriented with technical materials
  • Ability to meet deadlines while being flexible to changes in priorities and interruptions
  • Excellent organizational and analytical skills to complete assignments accurately
Job Responsibility
Job Responsibility
  • Develop best practices from a US Regulatory point of view
  • Coordinate and advise on regulatory activities in the US
  • Lead US Regulatory operational activities (artwork and formula reviews)
  • Review and approve North American – specific artwork for products
  • Work with Material Development/Coding to ensure that necessary updates are made to Coty formulation systems to enable product compliance in the US
  • Monitor US state and federal regulations impacting the cosmetic industry, to ensure Coty products are compliant
  • Provide Regulatory support to US commercial activities that enable marketing in national retailers
  • Provide guidance to Product Development regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines
  • Develop deep understanding and serve as internal expert for US relevant ingredient topics, contributing to Coty’s global ingredient policy development
  • Represent Coty on Personal Care Products Council’s ingredient defense task forces when relevant to Coty business
What we offer
What we offer
  • Health, dental, vision and disability insurance
  • 401(k) with generous employer match
  • paid time off and Summer Fridays
  • Parental leave
  • Tuition reimbursement
  • Hybrid work arrangements
  • Annual bonus based on business and individual performance
  • Fulltime
Read More
Arrow Right

Senior Manager, Regulatory Affairs

Location
Location
India , Thane
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
June 30, 2026
Flip Icon
Requirements
Requirements
  • Expert in Regulatory submissions in India
  • Minimum 12 years experience
  • Ability to translate strategical goals into tactical goals
  • Structured, analytical, systematic and independent way of working
  • Lead extensive project reengineering activities
  • Demonstrable ability in leading, mentoring, managing and motivation of staff
  • Ability to lead project teams
  • Ability to manage internal and external (client) relationships
  • Very good communication skills (written and verbally)
  • English business fluent
Job Responsibility
Job Responsibility
  • Develop and maintain strong client relationships
  • Participation in regulatory processes to gain and maintain marketing authorizations
  • Preparation, review and compilation of documents within the framework of regulatory affairs projects
  • Communication with clients and Health Authorities
  • Support with scientific advice procedures and representation of clients
  • Responsible for the planning and execution of client projects
  • Coordination of project teams
  • General guidance (consultancy) regarding Regulatory Strategy and Procedure Management
  • Regulatory intelligence
  • Present seminars and lectures
  • Fulltime
Read More
Arrow Right

Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

This position is responsible for leading CMC regulatory activities for investiga...
Location
Location
United States; Belgium; Italy; United Kingdom , Collegeville; Wavre; Durham; Siena; London; Waltham
Salary
Salary:
144375.00 - 240625.00 USD / Year
us.gsk.com Logo
GSK
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Life Sciences or related field
  • Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise
  • Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
  • Two or more years of experience completing project management tasks.
Job Responsibility
Job Responsibility
  • Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements
  • Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies
  • Mentors or trains staff
  • May have direct line management responsibility
  • Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate
  • Provides strategic direction, data assessment and conclusions within and across departments
  • Able to establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organisation
  • Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment)
  • May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs)
  • Has accountability for submission content
What we offer
What we offer
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Fulltime
Read More
Arrow Right

Senior Manager of Global Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...
Location
Location
United States , Deerfield
Salary
Salary:
136000.00 - 187000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree or country equivalent in a scientific discipline
  • Minimum of 7-year experience in RA
  • Expert Regulatory knowledge
  • Sound basis of Scientific (Training/ Communications) knowledge
  • Management skills
  • Ability to oversee multiple projects in a matrix team environment
  • Excellent oral and written communication and presentation skills
  • Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
  • Technical and management skills
  • Ability to lead, coach, and motivate others
Job Responsibility
Job Responsibility
  • Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
  • Provide technical and strategic input for regulatory decisions aligned with business strategy
  • Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
  • Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
  • Assess impact of new regulations and provide feedback
  • Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
  • Act as primary contact for meetings with regulatory authorities including planning and leadership
  • Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
  • Plan and manage complex projects and prioritize workload
  • Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
What we offer
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
Read More
Arrow Right

Senior Manager of Global Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...
Location
Location
United States , Deerfield
Salary
Salary:
136000.00 - 187000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree or country equivalent in a scientific discipline
  • Minimum of 7-year experience in RA
  • Expert Regulatory knowledge
  • Sound basis of Scientific (Training/ Communications) knowledge
  • Management skills
  • Ability to oversee multiple projects in a matrix team environment
  • Excellent oral and written communication and presentation skills
  • Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
  • Technical and management skills
  • Ability to lead, coach, and motivate others
Job Responsibility
Job Responsibility
  • Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
  • Provide technical and strategic input for regulatory decisions aligned with business strategy
  • Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
  • Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
  • Assess impact of new regulations and provide feedback
  • Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
  • Act as primary contact for meetings with regulatory authorities including planning and leadership
  • Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
  • Plan and manage complex projects and prioritize workload
  • Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
What we offer
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)
  • 401(k) Retirement Savings Plan (RSP)
  • 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
Read More
Arrow Right

Senior Regional Medical Affairs Manager Center South -Lung Cancer (RMAM)

You will lead regional medical affairs in your area of Germany, building trusted...
Location
Location
Germany , Munich
Salary
Salary:
Not provided
us.gsk.com Logo
GSK
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree in medicine, pharmacy, life sciences or related field (MD, PharmD, PhD or equivalent)
  • Minimum 3 years ideally experience in medical affairs, medical science liaison, clinical research in lung cancer
  • Strong clinical and scientific knowledge relevant to the therapy area
  • Excellent verbal and written communication skills in German and English
  • Willingness and ability to travel regularly within the assigned region
  • Solid understanding of regulatory, ethical and compliance requirements in the pharmaceutical environment.
Job Responsibility
Job Responsibility
  • Build and maintain scientific relationships with healthcare professionals and external clinical experts in the region
  • Deliver evidence-based medical education and scientific exchange in person and using digital channels for the area lung cancer
  • Respond to medical and scientific enquiries from healthcare professionals in a timely and compliant way
  • Support clinical research collaborations, including identifying study centres and enabling investigator-initiated research
  • Capture, synthesize and share local clinical insights to inform medical strategy and cross-functional planning
  • Plan and run regional medical activities such as advisory boards, symposia and educational meetings.
What we offer
What we offer
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes.
  • Fulltime
Read More
Arrow Right

Senior Biocompatibility & Toxicological Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to...
Location
Location
Germany , Bad Homburg
Salary
Salary:
Not provided
freseniusmedicalcare.com Logo
FMS USA Fresenius Mgmt Services Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Successfully completed master's degree in toxicology, chemistry, physics, life sciences, engineering, or a related field
  • Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
  • Solid expertise in biocompatibility evaluation and toxicological risk assessment
  • Experience in project management or cross-functional coordination
  • Strong knowledge of medical device regulations and standards (e.g. MDR 2017/745, ISO 13485, ISO 14971, ISO 10993 series, FDA 21 CFR Part 820)
  • Good understanding of global quality management systems and regulatory environments
  • Strong analytical skills, structured working style, and experience in scientific writing
  • knowledge of statistical methods is a plus
  • Ability to work independently and lead cross-functional topics without direct disciplinary authority
  • Proactive, solution-oriented mindset with strong organizational and communication skills
Job Responsibility
Job Responsibility
  • Lead biocompatibility and toxicology activities for a global medical device platform, including active devices and disposables
  • Define and drive the overall strategy for biological safety and toxicological evaluation across the product lifecycle
  • Take end-to-end accountability for key deliverables (e.g. biological evaluation plans/reports, toxicological risk assessments) in alignment with internal experts
  • Act as the central interface for cross-functional stakeholders, aligning requirements and prioritizing activities
  • Ensure compliant safety and risk assessments based on materials, extractables & leachables, and biocompatibility studies (ISO 10993)
  • Provide expert guidance and scientific assessments to support product development and regulatory submissions
  • Coordinate global biocompatibility activities and collaborate with internal competence centers, EHS, and Quality & Regulatory teams
  • Contribute to design control, regulatory compliance, and continuous improvement initiatives, including sustainability aspects
What we offer
What we offer
  • Individual opportunities for self-determined career planning and professional development
  • A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
  • A large number of committed people with a wide range of skills, talents and experience
  • The benefits of a successful global corporation with the collegial culture of a medium-sized company
  • Fulltime
Read More
Arrow Right

Senior EMEA REACH Expert

A rare opportunity to join the product stewardship department at a major global ...
Location
Location
United Kingdom
Salary
Salary:
Not provided
vrs-regulatory.net Logo
VRS Regulatory
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Solid track record in chemical or inorganic/metals industries
  • Deep working knowledge of REACH
  • Proven ability to ensure EEA REACH Regulatory compliance
  • Excellent interpersonal skills
  • Mix of business acumen and regulatory expertise
Job Responsibility
Job Responsibility
  • Ensure high levels of compliance with EU REACH, Turkey REACH (KKDIK), UK REACH and other emerging schemes
  • Provide expert support to ensure business continuity
  • Keep abreast of all developments in REACH like regulatory frameworks across the EMEA
  • Identify business risks and opportunities
  • Engage with internal stakeholders to provide expert support
  • Define and manage work carried out by external consultants
  • Work with industry groups and consortia on broader industry scientific and regulatory issues
  • Develop the strategy and manage the technical work done by external consultants
Read More
Arrow Right