Senior Manager, Regulatory Affairs Job at Beam Therapeutics (Cambridge)

Senior Manager, Regulatory Affairs

The mission of the Regulatory Affairs group is to implement effective processes ...

Location

United States , St Louis

Salary:

122187.50 - 158125.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
7 years of Regulatory Affairs experience
Minimum of 7 years of US EPA Antimicrobial registration experience
US State Registration experience
Leadership experience managing a team of people
Ability to travel as noted above

Job Responsibility

Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compliance requirements for marketing STERIS products in their assigned areas or regions where STERIS does business
Effectively interface with government agencies, notified bodies, consultants and authorized dealer representatives as necessary to address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management
Provide regulatory guidance and support to project teams and STERIS internal Customers to support new product development and existing product lines in support of registration requirements.
Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified.
Gather information and documentation on new or modified products to determine submission requirements for particular markets.
Compile and create document registration packages through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities.
Critically assess the strength and completeness of documentation created by others
advise improvements to comply with current requirements for particular regulatory authorities.
See that all direct team members maintain submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Report to management concerning current, pending, and re-registration approvals. Identify and take action on any unexpected delays

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Senior Manager, Regulatory Affairs (Ad Promo)

As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse cli...

Location

United States , Raleigh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience
US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry
Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction
Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail
Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

Job Responsibility

Participate in provision of regulatory expertise in strategic drug development across multiple areas
Take part in preparation of strategic development and submission plans
Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally)
Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities
Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

(Senior) Manager, Regulatory Affairs

We are working with a leading pharmaceutical company who are seeking an experien...

Location

United Kingdom , Maidenhead

Salary:

70.00 - 85.00 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences discipline
Strong experience in European Regulatory Affairs, including centralised, MRP/DCP and national procedures
Proven track record leading regulatory activities for development products (e.g., scientific advice, PIP)
Effective communicator able to work across complex international and matrixed environments
Strong leadership, organisational skills and ability to work independently with minimal supervision

Job Responsibility

Lead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe Area
Represent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategy
Collaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activities
Assess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvals
Monitor evolving European legislation and lead the development of regulatory responses and policy implementation

Parttime

Senior Regulatory Affairs Manager

Facilitates and supports the regulatory and drug development requirements of ext...

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred
8+ years experience in veterinary regulatory and/or animal drug development
Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA
Development and regulatory experience with food animal drugs is preferred but not required
Good written and oral communication skills, and ability to work collaboratively within and across teams
Results and bottom line oriented
Excellent analytical skills and attention to detail
Proven influence, negotiation and persuasion skills
Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs

Job Responsibility

Facilitates and supports the regulatory and drug development requirements of external clients and internal projects
Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications
Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges
Creates regulatory solutions to complex issues
Provides client accurate expert regulatory advice on animal health product development
Represent Argenta in industry associations (e.g. GADA, AHI, SQA)
Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications

Fulltime

Eu Regulatory Affairs Senior Manager (Biosimilars)

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated in a scientific discipline
Extensive experience of the regional Biosimilars regulatory environment
Proven track record of developing and executing regional Biosimilars regulatory strategy
In-depth understanding of the drug life cycle and development process from a regulatory perspective
In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Ability to lead teams and work collaboratively in a dynamic environment
Proactive approach to problem solving
Ability to understand and communicate scientific/clinical information
Ability to anticipate regulatory agency expectations
Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

Job Responsibility

Plan and manage regulatory submissions for products within Amgen's biosimilar portfolio in compliance with global filing plans and local regulatory requirements
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
Lead development of regional regulatory documents and meetings in accordance with GRT strategy
Provide regulatory direction on regional regulatory mechanisms to optimize product development
Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise on regulatory implications and requirements related to regional development plans and objectives
Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Ensure and lead regulatory compliance for biosimilar products (eg, agency commitments)
Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning

What we offer

Growth 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

Eu Regulatory Affairs Senior Manager - General Medicine

In this vital role you will work to ensure that Amgen acquires and maintains all...

Location

United Kingdom; Portugal , Cambridge; Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated in a scientific discipline
Extensive experience in regional regulatory environment
Proven track record of developing and executing regional regulatory strategy
In-depth understanding of the drug life cycle and development process from a regulatory perspective
In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Ability to lead teams and work collaboratively in a dynamic environment
Proactive approach to problem solving
Ability to understand and communicate scientific/clinical information
Ability to anticipate regulatory agency expectations
Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

Job Responsibility

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
Lead development of regional regulatory documents and meetings in accordance with GRT strategy
Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately

What we offer

Growth 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
flexibility to work from home

Fulltime

Regulatory Affairs Senior Manager – Obesity and Related Conditions

Amgen is seeking a United States Regulatory Lead (USRL) supporting products in t...

Location

United States , Remote; Deerfield; Washington D.C.

Salary:

142579.00 - 192901.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of regulatory experience
Master’s degree and 4 years of regulatory experience
Bachelor’s degree and 6 years of regulatory experience
Associate’s degree and 10 years of regulatory experience
High school diploma / GED and 12 years of regulatory experience
Demonstrated experience with U.S. regulatory submissions and direct FDA interaction, with strong knowledge of the U.S. regulatory environment and drug development lifecycle
Experience contributing to regulatory strategy, including risk assessment, scenario planning, and Health Authority engagement in partnership with global leadership.

Job Responsibility

Contribute to the development and refinement of global regulatory strategy in partnership with the GRL, providing U.S.-specific insights on regulatory precedent, risk, and Health Authority expectations in obesity and related metabolic conditions
Apply scientific expertise in obesity and metabolic disease to inform regulatory strategy, including clinical endpoints and long-term safety considerations
Partner with the GRL and key market leads to align on global development timelines, core documents (e.g., protocols, IBs, KDEs), and regulatory positioning
Execute the U.S. regulatory strategy for assigned programs and represent the region on global governance teams
Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements
Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy
Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group, including negotiation approach, timelines, and deviation/waiver decisions
Provide strategic input on U.S. development pathways (e.g., expedited programs, orphan designation, pediatric strategy), informed by the evolving regulatory landscape
Lead Health Authority interactions for assigned products, including preparing and leading engagements and communicating outcomes to the GRT and senior management
Manage responses to agency questions (RTQs) and feedback by coordinating cross-functional input and ensuring timely, high-quality submissions

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

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Senior Manager, Regulatory Affairs

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