Regulatory Associate Job at Douglas Scott (Manchester)

Senior/Principal Associate - Regulatory

We are now seeking an ambitious Senior Associate/Principal Associate to join our...

Location

United Kingdom , Leeds or Manchester

Salary:

Not provided

Capsticks Solicitors LLP

Expiration Date

Until further notice

Requirements

Prepare the case plan at the outset of the case
Prepare advice on procedural or evidential issues
Correspond with the defence
Ensure that all factual evidence required to prove the allegations is obtained
Are the key point of contact for all witnesses
Interview key witnesses in complex cases or if the witness deals with novel or sensitive issues or is a vulnerable witness
Supervise witness statements taken by paralegals
Instruct experts and identify if any amendments are necessary to the expert report
Prepare instructions to counsel (both our internal advocates and the external bar)
Attend conferences with counsel

Job Responsibility

Managing an investigatory caseload where it is alleged that the registrant's fitness to practise is impaired through misconduct, competence or health issues and preparing those cases for hearings before panels and committees of the relevant regulators.

What we offer

Competitive Salary & Benefits

Fulltime

Healthcare Regulatory Associate

My client is a national top tier law firm, and they are looking to recruit a Hea...

Location

United Kingdom , Birmingham

Salary:

59000.00 - 68000.00 GBP / Year

Douglas Scott

Expiration Date

Until further notice

Requirements

3–8 years PQE
experience in healthcare regulatory law, including advocacy
a proactive, client-focused approach

Job Responsibility

advocacy at inquests, Court of Protection hearings, and Tribunals
advisory work on complex regulatory matters
opportunities to get involved in strategic business development initiatives

What we offer

generous bonus scheme
enhanced benefits including private healthcare, enhanced maternity/paternity, 25 days annual leave (with buy/sell options)
flexible hybrid working
strong support for career progression with direct mentorship from Partners

Fulltime

Healthcare Regulatory Senior Associate

My client is a national top tier law firm, and they are looking to recruit a Hea...

Location

United Kingdom , Birmingham

Salary:

75000.00 - 90000.00 GBP / Year

Douglas Scott

Expiration Date

Until further notice

Requirements

8+ years PQE
Experience in healthcare regulatory law, including advocacy
A proactive, client-focused approach

Job Responsibility

Advise clients across the health, social care, and education sectors on a broad range of regulatory issues, both contentious and non-contentious
Manage a varied caseload that includes advocacy at inquests, Court of Protection hearings, and Tribunals
Advisory work on complex regulatory matters
Get involved in strategic business development initiatives
Supervise Solicitors within the team

What we offer

Private healthcare
Enhanced maternity/paternity
25 days annual leave (with buy/sell options)
Generous bonus scheme
Flexible hybrid working
Strong support for career progression, with direct mentorship from Partners and early responsibility

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

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

Healthcare Regulatory Associate

My client are a leading UK defendant firm seeking an experienced Healthcare Regu...

Location

United Kingdom , Greater Manchester

Salary:

45000.00 - 57000.00 GBP / Year

Douglas Scott

Expiration Date

Until further notice

Requirements

Managing your own varied caseload of both advisory and litigation matters
Advocacy at inquests, Court of Protection hearings and Tribunals
Active involvement in client care and business development

Job Responsibility

Managing your own varied caseload of both advisory and litigation matters
Advocacy at inquests, Court of Protection hearings and Tribunals
Active involvement in client care and business development

What we offer

Flexible/hybrid working (minimal office attendance required)
Flexible annual leave allowance
Performance related bonuses
Private medical insurance

Fulltime

Senior Associate Data Management

The Senior Associate, Data Management, will help drive key business operation in...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
In depth understanding of the Veeva Vault system
Good written and verbal communication skills
Detail oriented
Independent time management and prioritization skills
Work efficiently with little support and minimal to no supervision
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
Critical thinking skills
Appropriate software skills as required
Strong analytical and problem solving, communication and presentation skills

Job Responsibility

Responsible for maintaining data within the Regulatory Information Management (RIM) system
Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
Serve as a Data Management SME within cross-functional collaborative initiatives
Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
Provide support on creating, running and analysing reports for data streamline projects
Develop and deliver training materials and presentations to a global audience
Manage the protocol Amendment New Investigator (PANI) submission updates
Manage 1572 forms for FDA submission
Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods
Adhere to Amgen processes, policies, guidelines, SOPs and training documentations

What we offer

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Senior Associate

Senior Associate position in the Dopkins Assurance Services Group. The role invo...

Location

United States , Buffalo

Salary:

Not provided

Dopkins & Company, LLP

Expiration Date

Until further notice

Requirements

Taking responsibility for client work being performed on time, appropriate scope of services and within budget
Taking responsibility for service quality, thoroughness and accuracy
Staying current on regulatory and industry issues and shares applicable information with others
Managing risk in the client service process by following professional standards
Keeping current with a changing Federal and State regulatory environment
Assessing problem/issue materiality and interpreting the implications for the client
Consistently taking on work outside of “comfort zone”, asking for stretch assignments to develop
Conducting self-review to ensure work is complete and no open issues exist
Demonstrating an understanding of and applying assurance-based concepts
Developing the ability to recognize assurance issues

What we offer

Access to department and Firm leaders at all levels through our open-door policy
Opportunity to serve a wide array of clients, as to size, complexity and industry
Opportunity to advance your career based upon hard work and merit
Close-knit group of young professionals who work well together and with whom you develop friendships
Strong support to develop technical expertise
Be recognized, and also recognize your peers for exceptional service, through the Firm’s internal communications system

Regulatory Associate

Douglas Scott

Location:
United Kingdom , Manchester

Category:
Legal

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
June 27, 2025

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