Senior Scientific and Regulatory Affairs Expert Job at Life Science Talent (København)

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Senior Manager, Global Medical Affairs (Menopause)

This role is pivotal in providing subject matter knowledge and expertise, develo...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Medical degree with GMC registration or equivalent international qualification or Master of Pharmacy with GPhC registration
Previous experience in Medical Affairs, Clinical Research, or Pharmacovigilance within the pharmaceutical industry
Very good understanding of Medical Affairs’ role as scientific enabler and strategic partner in a pharmaceutical company
Strong knowledge and subject matter in women’s health
Ability to cut through scientific complexity and to communicate precisely and clearly with different target audiences
Strong interpersonal and leadership skills and track record of expertise working in a cross-functional environment
Strong analytical and strategic thinking
Strong business acumen
Highest professional work ethics
Proven knowledge of the ABPI Code of Practice and codes of international associations of the pharmaceutical industry, with experience in reviewing and/or certifying materials

Job Responsibility

Develop and implement medical plans aligned with business objectives and manage associated budgets
Provide expert medical input across the product lifecycle, including: Evidence generation
Evidence dissemination (e.g. health care professional education programs)
Medical experts’ engagement programs (e.g. advisory boards)
Build and maintain relationships with international therapy area experts and medical-scientific professional societies
Act as a medical reviewer for promotional and non-promotional materials in line with the ABPI and international associations of the pharmaceutical industry codes as well as internal SOPs
Support regulatory and market access submissions with clinical content
Ensure compliance with all relevant regulations and contribute to continuous process improvement
Ensure operational excellence

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

Senior Manager, Regulatory Affairs

Location

India , Thane

Salary:

Not provided

Cencora

Expiration Date

June 30, 2026

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

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

Senior Manager of Global Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...

Location

United States , Deerfield

Salary:

136000.00 - 187000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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 Manager of Global Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...

Location

United States , Deerfield

Salary:

136000.00 - 187000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Manager, Regulatory Global Labeling

This position will be responsible for leading the development, review, and manag...

Location

United States , San Rafael

Salary:

108000.00 - 162000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
2+ years in Regulatory Affairs
Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
US and/or EU Labeling experience minimally required and core labeling experience highly desired
Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
Experience with E2E global labeling processes and management of Company Core Data Sheets
Experience in review process, standards, and industry best practice pertaining to labeling
Strong scientific background and/or experience
Working knowledge of medical terminology and drug safety

Job Responsibility

Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
Ensure appropriate labeling strategies are communicated to project teams
Ensure labeling is compliant with core labeling and local regulations
Ensure labeling is accurate and of the highest quality
Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
Lead the assigned product labeling teams (PLTs) and support labeling positions
Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Regulatory Project Manager

At GSK, we’re constantly developing new products and improving our established m...

Location

Poland , Poznan; Warsaw

Salary:

236250.00 - 393750.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

Job Responsibility

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

What we offer

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Fulltime

Senior Manager, US Regulatory Affairs and Ingredient Support

COTY is looking for smart leaders who are fast and passionate! We challenge conv...

Location

United States , Morris Plains

Salary:

110000.00 - 135000.00 USD / Year

Coty Inc.

Expiration Date

Until further notice

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

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

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

Senior Scientific and Regulatory Affairs Expert

Life Science Talent

Location:
Denmark , København

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 14, 2026

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Japan Regulatory Strategy Group Senior Manager