Sr Associate Regulatory Affairs Job at Amgen (Prague)

Sr Associate Regulatory Affairs

The Local Regulatory Representative (Sr. Associate) is assigned to one or more A...

Location

South Korea , Seoul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

At least 5 years of directly related experience
Business-level proficiency in Korean and English is required
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
Understanding of drug development
Under general supervision interact with local health and regulatory authorities for routine matters
Demonstrate ability to work in teams
Ability to understand and communicate scientific/clinical information

Job Responsibility

Assist in aligning local regulatory requirements with Amgen’s corporate standards
Provide national/regional input to and execute regulatory strategies
Plan and manage local regulatory submissions
Ensure local labels are developed and maintained
Act as the point of contact with regulatory agencies
Plan and manage clinical trial applications through CRO
Manage CRO work invoice and participate in global network
Work as a point of contact and oversight for Global Regulatory Affairs & Strategy
Contributes for the filing plan
Executes the filing plan

New

Sr Associate Regulatory Affairs - CMC

If you feel like you're part of something bigger, it's because you are. At Amgen...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Background in CMC related functions (e.g., Quality, Manufacturing, etc) with limited or no prior Regulatory Affairs experience
Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast-paced learning environment
Developed project management and organizational skills
Strong and effective oral and written communication skills

Job Responsibility

Contribute as a key member of the global regulatory CMC product team
Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Sr Associate, Manufacturing Regulatory

The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Industrial Chemistry
A Master's degree in Regulatory Affairs is considered a strong asset
1–2 years of experience in Regulatory Affairs within pharmaceutical companies, preferably in an international environment
Fluent in English (written and spoken)
Good proficiency with standard IT tools and basic statistical analysis
Strong attention to detail and quality-oriented mindset
Proactive, results-driven approach with the ability to manage assigned responsibilities independently
Excellent communication and interpersonal skills
Ability to work effectively in cross-functional teams

Job Responsibility

Assess regulatory impact of changes related to manufacturing sites, processes, and products
Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
Draft and review documentation supporting CMC variations and manufacturing changes
Prepare product-specific regulatory declarations and contribute to Product Quality Reviews (PQRs)
Collaborate cross-functionally with Quality, Manufacturing, and other relevant departments to ensure alignment on regulatory strategies and timelines
Support continuous improvement initiatives to ensure ongoing compliance with regulatory standards

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

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

Senior Director Regulatory Affairs

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

Location

United States , Chicago

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 , Washington, DC

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
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
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

Sr. Manager - Government & External Affairs

The Sr. Manager, Government Affairs at T-Mobile is responsible for helping lead ...

Location

United States , Remote - Use Home Address, Various, California

Salary:

119700.00 - 215900.00 USD / Year

T-Mobile

Expiration Date

Until further notice

Requirements

Bachelor’s degree in public policy, Political Science, Law, Communications, or related field
Masters Preferred
5-10 years’ experience in government affairs, public policy, strategic alliances, or legislative advocacy, preferably within the telecommunications or technology industries
Strong understanding of federal, state, and local government processes and regulations affecting telecommunications
5+ years building and maintaining relationships with key government officials and demonstrated ability to influence public policy outcomes
Strategic Thinking: Ability to develop and implement effective strategies that align with the company's business goals and regulatory environment
Relationship Management: Capability to build and maintain strong relationships with government officials, regulatory bodies, and third-party organizations
Collaboration: Ability to work collaboratively in a fast-paced, dynamic environment
Strategic Planning: Proficiency in planning long-term strategies that incorporate public policy trends and regulatory changes
Leadership: Strong leadership skills to guide and influence both internal teams and external stakeholders

Job Responsibility

With emphasis in California, develop and implement comprehensive government affairs strategies to support T-Mobile’s business goals and policy priorities
Represent T-Mobile before non-profit organizations, legislators, regulators, and other governmental officials at all levels
Advocate for policies that promote innovation, competition, and consumer benefits in the wireless sector
Build coalitions with industry partners, think tanks, trade associations, and community organizations to amplify T-Mobile’s voice
Coordinate with internal teams, including Legal, Compliance, and Public Relations, to ensure unified messaging and strategy

What we offer

Competitive base salary and compensation package
Annual stock grant
Employee stock purchase plan
401(k)
Access to free, year-round money coaches
Medical, dental and vision insurance
Flexible spending account
Paid time off and up to 12 paid holidays
Paid parental and family leave
Family building benefits

Fulltime

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Sr Associate Regulatory Affairs

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