Associate Director, Regulatory Affairs Job at Baxter (Deerfield)

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

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science
Master’s degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Job Responsibility

To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide 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
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

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 5 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

The Senior Director of Regulatory Affairs is responsible for assuring that all d...

Location

United States , Columbia

Salary:

137846.78 - 241870.90 USD / Year

Adtalem Global Education

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, Master's Degree preferred
Minimum 10 years experience in a heavily regulated environment
preferably within post-secondary education required
Title IV compliance experience preferred
At least 5 years of supervisory experience
Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
Strong interpersonal, organizational, writing, editing, and computer skills are required
Strong understanding of federal Title IV regulations

Job Responsibility

Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues, achieving strategic and compliance objectives of the organization
Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
Recommends business practice changes to improve compliance with higher education laws and regulations
Ensures that corrections in the areas of non-compliance are made timely and accurately
In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements in the areas of academics, career services, enrollment management, state and provincial licensing, student finance, and student services
Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
Utilizing both internal and external resources, supports efforts to influence federal and state regulation development. Serves as a resource for Adtalem’s Government Relations team on legislative matters related to institutions of higher education

What we offer

Health, dental, vision, life and disability insurance
401k Retirement Program + 6% employer match
Participation in Adtalem’s Flexible Time Off (FTO) Policy
12 Paid Holidays
Eligible to participate in an annual incentive program

Fulltime

Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...

Location

United States , Minneapolis

Salary:

137846.78 - 241870.90 USD / Year

Adtalem Global Education

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, Master's Degree preferred
Minimum 10 years experience in a heavily regulated environment
preferably within post-secondary education required
Title IV compliance experience preferred
At least 5 years of supervisory experience
Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
Strong interpersonal, organizational, writing, editing, and computer skills are required
Strong understanding of federal Title IV regulations.

Job Responsibility

Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues, achieving strategic and compliance objectives of the organization
Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
Recommends business practice changes to improve compliance with higher education laws and regulations
Ensures that corrections in the areas of non-compliance are made timely and accurately
In coordination with the appropriate organization managers, reviews proposed process changes to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements
Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
Utilizing both internal and external resources, supports efforts to influence federal and state regulation development

What we offer

Health, dental, vision, life and disability insurance
401k Retirement Program + 6% employer match
Participation in Adtalem’s Flexible Time Off (FTO) Policy
12 Paid Holidays
Eligible to participate in an annual incentive program

Fulltime

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Associate Director, Regulatory Affairs

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