Director, BE Regulatory Relations Job at Barclays (Paris)

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Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States

Salary:

189632.45 - 256561.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly related experience
Master's degree and 8 years of directly related experience
Bachelor's degree and 10 years of directly related experience
at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan
Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling
Provides regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
Leads development, review and approval of the target product label (TPL)
Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance
Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents)
Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions
Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment
Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Associate Director, Regulatory Affairs

Responsible for global strategic planning of the portfolio within a business uni...

Location

United States , Deerfield

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Masters and/or PhD will be an advantage
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities

Job Responsibility

Develop and implement regulatory strategy aligned with business strategy
Lead FDA, EU MDR and global submission strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions
Act as primary contact for meetings with the regulatory authorities including the planning and leadership
Implement policies to ensure ongoing compliance with regulatory requirements
May manage regulatory budget at project level
Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms
May represent Baxter interests in industry and working groups

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
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
Paid parental leave

Fulltime

Associate Director, Regulatory Affairs

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Deerfield, Illinois

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities
Demonstrated ability to lead, mentor, and develop others for future growth and development

Job Responsibility

Responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards
Leads, mentors, and develops others in service of Baxter's objectives in alignment with PSS’s hospital bed segment
Participates in strategic LRP and AOP for Hospital Beds
Responsible for all aspects of regulatory strategy for the PSS hospital bed product segment
Provides quarterly regulatory intelligence impact assessments for Batesville, IN site
Oversee Notified Body consolidation activities for the PSS hospital bed group
Lead regulatory efforts for consistent delivery of CCS business objectives
regulatory policy and implementation
and identification and prioritization of key opportunities and risks
Mentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects

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
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

Global Regulatory Director Lead – Obesity & Related Conditions (Type II Diabetes)

The Director, Global Regulatory Lead (GRL) provides strategic regulatory leaders...

Location

United States

Salary:

189632.45 - 256561.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of regulatory experience OR Master's degree and 7 years of regulatory experience OR Bachelor's degree and 9 years of regulatory experience
8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas
Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints
Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies
Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues
Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks
Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations
Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus

Job Responsibility

Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science
Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions
Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways
Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans
Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams
Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues
Translate complex metabolic science into actionable regulatory strategy
Oversee execution of major global regulatory submissions
Ensure consistency, scientific rigor, and clarity across core regulatory documents
Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Director - Regulatory Intelligence

Director - Regulatory Intelligence will oversee the Group’s external facing regu...

Location

Ireland , Cashel; Dublin; London; Leeds; Luxembourg

Salary:

Not provided

Waystone Governance Ltd.

Expiration Date

Until further notice

Requirements

An internationally recognised professional qualification
Strong academic background including at minimum a degree in law, business, economics or related field
Minimum of 10 years in professional services, preferably in the funds industry or law firm
Proven success and advancement within a risk, research, legal, compliance or portfolio management team
Networking skills, be highly motivated, and adept at building relationships
Capacity to apply real-world research to the Waystone’s business model
Client-facing background with strong presentation skills
Outstanding time management, organisational skills, oral/written communication skills, critical thinking and attention to detail is required
Must be able to work in a fast-paced environment including reporting and providing support to various members of the team
Strong MS Office Skills

Job Responsibility

Work closely with the Group Head of Horizon Scanning to agree effective methods of monitoring all relevant market and regulatory developments that may impact the Group’s clients, prospective clients, or delegates (in particular, Investment Managers) and maintain a centralised, easily accessible repository of regulatory updates and insights
Work with Waystone’s industry forum representatives to collate, assess and interpret global developments impacting our products and clients
Develop and deliver regular (monthly/quarterly) client newsletters summarising regulatory and market changes, tailored by client type and jurisdiction
Create and deliver targeted client briefings, webinars, and thought leadership on significant changes, including preparation of communications for LinkedIn and website publication by Group Senior Management or the Director of Regulatory Intelligence as appropriate
Partner with Product teams and Business Development and to translate regulatory change into new or enhanced product offerings
seeking opportunities for revenue growth
Coordinate with Compliance and Legal (local or Group as needed) to ensure consistency, accuracy and regulatory compliance in client communications
Support the training and enablement of internal teams to ensure regulatory changes are understood and leveraged effectively in client discussions
Support the Relationship Managers and Key Account Managers including with regulatory updates for use in Board Reports
Provide technical sales support through training the Business Development team in new regulation, new product offerings and changes to existing products, supported by impact and change analysis by the Group Head of Horizon Scanning

Parttime

Director - Regulatory Intelligence

Director - Regulatory Intelligence will oversee the Group’s external facing regu...

Location

United Kingdom

Salary:

Not provided

Waystone Governance Ltd.

Expiration Date

Until further notice

Requirements

An internationally recognised professional qualification
Strong academic background including at minimum a degree in law, business, economics or related field
Minimum of 10 years in professional services, preferably in the funds industry or law firm
Proven success and advancement within a risk, research, legal, compliance or portfolio management team
Networking skills, be highly motivated, and adept at building relationships
Capacity to apply real-world research to the Waystone’s business model
Client-facing background with strong presentation skills
Outstanding time management, organisational skills, oral/written communication skills, critical thinking and attention to detail is required
Must be able to work in a fast-paced environment including reporting and providing support to various members of the team
Strong MS Office Skills

Job Responsibility

Work closely with the Group Head of Horizon Scanning to agree effective methods of monitoring all relevant market and regulatory developments that may impact the Group’s clients, prospective clients, or delegates (in particular, Investment Managers) and maintain a centralised, easily accessible repository of regulatory updates and insights
Work with Waystone’s industry forum representatives to collate, assess and interpret global developments impacting our products and clients
Develop and deliver regular (monthly/quarterly) client newsletters summarising regulatory and market changes, tailored by client type and jurisdiction
Create and deliver targeted client briefings, webinars, and thought leadership on significant changes, including preparation of communications for LinkedIn and website publication by Group Senior Management or the Director of Regulatory Intelligence as appropriate
Partner with Product teams and Business Development and to translate regulatory change into new or enhanced product offerings
seeking opportunities for revenue growth
Coordinate with Compliance and Legal (local or Group as needed) to ensure consistency, accuracy and regulatory compliance in client communications
Support the training and enablement of internal teams to ensure regulatory changes are understood and leveraged effectively in client discussions
Support the Relationship Managers and Key Account Managers including with regulatory updates for use in Board Reports
Provide technical sales support through training the Business Development team in new regulation, new product offerings and changes to existing products, supported by impact and change analysis by the Group Head of Horizon Scanning

Parttime

Director, Regulatory

We are seeking an experienced and highly motivated professional to join our team...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 8 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Senior Director, Regulatory Affairs

Senior Director role in Regulatory Affairs at Beam Therapeutics, a biotechnology...

Location

United States , Cambridge

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or foreign equivalent, in regulatory affairs
or a closely related field
Five (5) years of progressive, post-baccalaureate experience including: Working in regulatory affairs
Developing regulatory documents and submissions
and Presenting corporate development programs to regulatory agencies
The required five years must also include at least one year of experience (which may have been gained concurrently) involving: Regulatory affairs work within biotechnology specifically, including application of U.S. and global regulatory procedures and practices
Developing regulatory documents and submissions such as IND, CTA/IMPD, BLA, MAA and PIP
and Managing projects in biotechnology regulatory affairs

Job Responsibility

Supporting development and implementation of global regulatory strategy for innovative genetic medicine programs within a fast-paced biotechnology environment
Ensuring integration of regulatory tactics with broader corporate strategy across non-clinical, clinical and commercial development stages
Incorporating evolving United States and global regulatory requirements related to gene editing, gene therapy, rare disease, orphan indications, breakthrough therapies and expedited regulatory pathways
Representing the Regulatory Affairs function on cross-functional and project teams to provide regulatory input throughout development
Developing innovative regulatory approaches, solutions and guidance while mitigating regulatory risks
Collaborating with external stakeholders, including experts, consultants and contracted vendors
Guiding planning, preparation, construction and submission of regulatory documentation
Managing project plans, timelines and prioritization to ensure milestones and goals are achieved
Providing regulatory due diligence support

Fulltime

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Director, BE Regulatory Relations

Job Description

Job Responsibility

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