Senior Director Regulatory Affairs Job at Adtalem Global Education (Chicago)

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

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

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Senior Director of Renewables, Campaigns

The Senior Director of Renewables, Campaigns will focus on advancing renewable e...

Location

United States

Salary:

140000.00 - 155000.00 USD / Year

Action for the Climate Emergency

Expiration Date

Until further notice

Requirements

10+ years of experience in the US power sector with expertise in renewable energy development, regulatory permitting, stakeholder engagement, policy advocacy, or public affairs within the energy industry
Bachelor's degree in a relevant field or equivalent experience
Demonstrated ability to design and execute campaigns, particularly at the state and local levels
Exceptional communication and writing skills
Proven experience building coalitions and engaging stakeholders across sectors
Demonstrated expertise in researching and analyzing policy and regulatory landscapes
Experience using renewable energy databases like Enverus, Curate, Landgate and AI tools
Strategic thinking capabilities with deep understanding of data use and ability to inspire and lead diverse teams
Strong project management skills
Self-starter who is proactive, flexible, and solutions-oriented

Job Responsibility

Support strategy development including drafting internal and external plans, memos and playbooks for accelerating deployment
Share and leverage subject matter expertise in community engagement, stakeholder relations, and project deployment across a variety of renewable energy technologies
Develop guides and collateral for engaging with local officials, stakeholders, and communities to promote renewable energy projects
Build and maintain relationships with renewable energy developers, policymakers, community leaders, funders, partners and other key stakeholders
Draft reports, memos, letters and other communications funders, developer clients, and other critical stakeholders as needed
Support advocacy efforts for policy and regulatory changes that streamline renewable energy deployment locally, at the state-level and nationally where applicable
Represent the organization at industry events, public hearings, and community forums to promote renewable energy initiatives
Support community engagement efforts with partners and other stakeholders, including town halls, community events, or other opportunities
Identify and analyze regulatory and policy opportunities to support renewable energy permitting and development-friendly ordinances
Conduct research on advocacy strategies, regulatory barriers, and best practices to inform campaign and outreach efforts

What we offer

Medical
Dental
Vision
403b retirement savings plan
Vacation
Sabbatical
Paid Parental Leave
2 Floating Holidays
2 Community Service Floating Holidays
Sick time

Fulltime

Director Legal Affairs

We are a fast-paced, growth-driven company seeking an experienced and business-m...

Location

United States of America , San Antonio

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Licensed Attorney: Active license to practice law in good standing in at least one U.S. jurisdiction
Experience: Minimum of 10 years of legal practice, ideally a combination of top-tier law firm and in-house corporate legal department experience
Industry Expertise: Strong experience advising clients in the retail, convenience store, or petroleum industries highly preferred
Legal Skillset: Mastery in contract drafting, negotiation, regulatory compliance, privacy, and business counseling
Exceptional Communicator: Outstanding writing, verbal communication, and interpersonal skills, with the ability to influence and advise senior leadership
Self-Starter with Collaborative Spirit: Ability to work independently while thriving in a cross-functional, global environment
Relationship-Builder: Proven track record of developing strong internal and external professional relationships
Organized and Detail-Oriented: Excellent organizational skills with the ability to manage multiple complex projects simultaneously under tight deadlines
Positive and Strategic Mindset: A proactive, solutions-oriented approach with a positive attitude and a strong commitment to excellence

Job Responsibility

Serve as a trusted advisor to senior management, offering strategic guidance that balances legal risk with business objectives
Draft, negotiate, and review contracts at global, national, regional, and local levels across procurement, fuel operations, IT, marketing, and general business operations
Provide strategic counsel to global fuel teams on supply, distribution, regulatory, and transactional matters
Navigate a broad regulatory landscape, ensuring compliance with FTC competition laws, liquor licensing, environmental regulations, lottery rules, and local/state legal requirements
Oversee privacy compliance initiatives to ensure alignment with evolving U.S. privacy laws and regulations
review and negotiate privacy-related contracts
Review, draft, and negotiate IT contracts and technology agreements
Support marketing initiatives by drafting disclaimers, contest rules, terms and conditions, and providing risk mitigation advice on promotions and campaigns
Identify, recommend, and implement improvements that streamline legal department operations and enhance overall business efficiency
Provide education, training, and mentoring to internal legal team members and business units

What we offer

Work closely with executive leadership on critical business initiatives
Support a growing, global company with diverse legal challenges
Opportunities for leadership and career advancement

Fulltime

Director, European Regulatory and R&D Policy

In this vital role you will be responsible for creating an optimal regulatory en...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree in public health, life sciences, public policy, business administration and/or law degree
Demonstrable experience in policy development, analysis and influencing
Demonstrable experience in successfully executing global regulatory policy strategies
Experienced solutions-orientated self-starter

Job Responsibility

Leading the development and execution of strategic plans for each assigned policy area
Ensure that Amgen’s regulatory, safety and R&D policy positions are successfully represented to inform policy development and implementation
Provide internal stakeholders with strategic regulatory policy perspectives
Guide and advise senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Support the creating of necessary infrastructure/processes for developing the regulatory policy function
Influence the development and articulation of Amgen’s position on regulatory policies that impact Amgen’s business
Represent Amgen in interactions with external regulatory, political, policy and professional organisations in a manner that aligns with the “one Amgen’ approach”

What we offer

Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act