Regulatory Job at Capsticks Solicitors LLP (Leeds or Manchester)

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

Legal & Regulatory Risk Lawyer / Senior Legal & Regulatory Risk Lawyer

The role of the OGC team at BCLP is to ensure that the firm and individuals with...

Location

United Kingdom , London

Salary:

Not provided

Bryan Cave Leighton Paisner LLP

Expiration Date

Until further notice

Requirements

Solicitor or barrister admitted in England & Wales or a similar common law jurisdiction
Experience of working in legal and regulatory compliance, ideally in an international law firm or for a legal regulator
Experience of working as a fee earner in private practice
Strongly service-oriented, with commercial acumen, and enthusiasm for the challenges of providing services and resources in a large, multi-office law firm setting
Ability to be flexible and adaptable to support the priorities and strategies of the firm
Strong technical IT skills and experience in the design, implementation or management of any technology-based compliance systems and processes (including the use of Gen AI tools) would be an advantage

Job Responsibility

Assist in managing the OGC team query in box (on a rota basis) and act as a first point of contact for internal legal and regulatory risk queries and as a point of escalation for junior lawyers and trainees, assisting them to finalise draft responses
Address various areas of legal and regulatory risk, including issues concerning the regulation and governance of the firm, the SRA Standards & Regulations, and a broad variety of issues concerning the business, its lawyers and other business professionals
Specific legal, regulatory and compliance areas of focus will include the following and will involve supervising and acting as an escalation point for more junior team members: responding to queries and working on projects relating to client engagement, limitation of liability, anti-bribery & corruption, share dealing, outside interests, referral fees, file transfer, escrow arrangements, confidentiality undertakings, NDAs, DAC6/UK MDR, and modern slavery
consideration of whether something is reportable to the SRA or other authority
responding to queries and working on projects relating to HR issues, including the on-boarding of lateral hire partners and/or teams, staff departures, supporting investigations where there might be a regulatory or other reporting obligation
drafting or reviewing and updating risk and compliance policies, procedures and guidance and reviewing and updating risk assessments
working as part of the wider Risk & Regulatory team on various projects to respond to key areas of legal/ regulatory risk to the firm or regulatory developments
supporting the legal and regulatory aspects of strategic projects
drafting and delivering compliance training to various groups, including new starters and trainees, mitigate key risks, educate and empower a risk aware and speak up culture
supporting the firm’s supplier procurement process by assisting with legal contract review

Fulltime

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Regulatory Compliance Engineer

This role has been designed as ‘’Onsite’ with an expectation that you will prima...

Location

United States , Roseville

Salary:

89400.00 - 206500.00 USD / Year

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

Must have 5-10 years of Regulatory compliance experience
Have a Bachelor’s or Master’s degree in electrical engineering
5-10 years of industry experience
Expert knowledge in EMI/EMC, Safety and Telecom standards/requirements for ITE/Telecom products
Proven track record managing global product certifications across development teams, test labs, suppliers, manufacturing, and OEM/ODM partners
Solid experience in acquiring global regulatory compliance approvals for new and released products
Experience working with Safety Agencies (UL, CSA, TUV) engineers early in the design phase to identify design constraints to achieve safety certification without surprises after the design freeze
Experience working with the relevant EMC Labs and various countries regulatory body such as FCC, IEC, CCC, EAC, KCC, Brazil Anatel, Taiwan BSMI, India TEC, EU etc…
Proven track record with performing or supporting the design and testing required to obtain Safety, EMC, Telecom, and similar certifications
Communicate regulatory strategy, testing required, approval schedule, estimated cost, key risks and concerns to the NPI program team

Job Responsibility

Leads the project team on internal and outsourced product development projects to design reliable, cost effective and high-quality EMC and safety compliance solutions for moderately to complex Networking products
Collaborates and communicates with management, internal, and outsourced development partners regarding design status, project progress, and issue resolution regarding regulatory compliance
Represents the electrical hardware team on all aspects of Global regulatory requirements in the product design phase
Provides regulatory compliance support to engineering development projects and existing product changes throughout the product life cycle
Interfaces with cross-functional teams consisting of engineering, operations, manufacturing, sourcing, quality, service, and marketing to assure ongoing products are compliant to global regulations
Solve complex Safety, EMC, Telecom test issues and challenges, including debugging/troubleshooting to recommend resolution

What we offer

Health & Wellbeing
Personal & Professional Development
Unconditional Inclusion

Fulltime

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Head of Regulatory Affairs

The Head of Regulatory Affairs is responsible for providing strategic leadership...

Location

India , Chennai

Salary:

Not provided

Randstad

Expiration Date

February 15, 2026

Requirements

Advanced degree (PharmD, PhD, MD, or MSc) in Life Sciences, Pharmacy, or a related field
Minimum of 10-15 years of experience in Regulatory Affairs
At least 5 years in a leadership role within a CRO or biopharmaceutical organization
Proven experience in global regulatory submissions and interactions with major health authorities (FDA, EMA, MHRA, CDSCO, etc.)
In-depth understanding of clinical development, GCP, and ICH guidelines
Strong track record in managing teams and leading complex regulatory projects across multiple therapeutic areas
Exceptional leadership, communication, and negotiation skills
Ability to translate complex regulatory requirements into practical strategies
Strong client relationship management and presentation abilities
High attention to detail with strong organizational and problem-solving skills

Job Responsibility

Develop and implement the CROs regulatory strategy aligned with corporate goals and client needs
Serve as the primary regulatory expert and advisor to senior management and project teams
Lead and mentor the Regulatory Affairs team
Build and maintain relationships with global regulatory agencies and industry associations
Oversee preparation, review, and submission of regulatory documents including INDs, NDAs, BLAs, ANDAs, IMPDs, CTAs, and other filings
Ensure regulatory compliance in all clinical trials
Develop and maintain global regulatory intelligence
Support clients with regulatory strategy, gap analysis, and submission planning
Establish and oversee systems for document management, tracking, and reporting of regulatory submissions
Partner with Business Development and Project Management teams to provide regulatory input during proposal development and client meetings

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

Regulatory

Capsticks Solicitors LLP

Location:
United Kingdom , Leeds or Manchester

Category:
Legal

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 03, 2026

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