Regulatory Affairs Associate Job at CK Group (Reading)

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

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

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

Federal Affairs Lead

Archer Aviation is hiring a Federal Affairs Lead to strengthen our efforts in sh...

Location

United States , Washington

Salary:

115000.00 - 154000.00 USD / Year

Archer Aviation

Expiration Date

Until further notice

Requirements

At least 3 years of relevant policy, regulatory, or government affairs experience
Bachelor’s degree in public policy, political science, or related field (Hill experience is preferred)
Familiarity with federal transportation, aerospace, or emerging technology policy
Strong written and verbal communication
being able to explain technical concepts to non-technical audiences
Proven ability to build and maintain relationships with government official’s staff, stakeholders and advocacy organizations
Skilled at analyzing policy documents and making clear, actionable recommendations

Job Responsibility

Support Archer’s federal government affairs strategy to advance policies that enable the growth of the AAM industry
Build and maintain strong relationships with key Congressional offices, federal agencies, and industry associations to advocate for Archer’s priorities
Monitor and analyze policy and regulatory developments
provide timely insights and recommendations to internal teams
Represent Archer at relevant D.C. events, conferences, and member organization meetings, ensuring the company’s voice is influential in shaping the future of AAM
Develop clear and compelling presentations, briefings, and advocacy materials for policymakers and regulators
Collaborate with internal teams to align policy strategy with business objectives and foster a results driven environment

Regulatory Specialist

Regulatory Specialist (East Windsor, NJ) (Multiple Openings).

Location

United States , East Windsor

Salary:

Not provided

Novitium Pharma

Expiration Date

Until further notice

Requirements

Must have bachelors in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related + 1 year exp. as Regulatory Specialist /Quality Control Analyst / Chemist / Analyst / Scientist/ Research Associate / Related

Job Responsibility

Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Tablet, Capsule, Liquid & Solutions)
responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS)
submitting dossiers electronically after the approval of initial product submissions (ANDA)
review of the leachable and extractable reports generated for the oral Liquid & Solution drug products

Intern, regulatory information management and technology

The BioMarin Summer Internship Program will enable students to gain valuable exp...

Location

United States

Salary:

24.00 - 27.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Knowledge of the Regulatory Affairs submission process
Proficient computer skills and working knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
Excellent interpersonal, written and verbal communication skills
Strong organizational skills with ability to prioritize and manage tasks in a fast-paced environment
Ability to work independently and collaboratively
Student pursuing a Bachelor’s degree in computerized systems or life sciences (or in related fields of study)
Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program
Must be available to work 40 hours a week
Must be authorized to work in the United States without visa sponsorship

Job Responsibility

Provide Regulatory Data Management and Regulatory Systems Usage/Implementation assistance for Global Regulatory Affairs RIMT group
Utilizing Information Management skills, provide Business Analysis to assist in enhancing existing Regulatory Information management data quality
Assess and reconcile regulatory details associated with Regulatory Health Authority Applications to support both Marketing and Investigational Drug Product authorizations
Providing support for Operational Change Management activities relating to technology improvements related to the Veeva RIM platform

What we offer

Paid hourly wage
Paid company holidays
Sick time
Apply skills and knowledge learned in the classroom to on-the-job experiences
Comprehensive, value-added project(s)
Develop skills specific to your major
Opportunities for professional development by building relationships and learning about other parts of the business
Participate in company all hands meetings, monthly community lunches
Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
Access to Employee Resource Groups

Fulltime

EU Affairs Officer

EU Affairs Officer position at METLEN Energy & Metals, responsible for monitorin...

Location

Belgium , Brussels

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Law, Finance, Engineering, Political Science or European Studies
Postgraduate Degree
Thorough understanding of the EU's institutions and legislative process
Knowledge of regulatory issues, especially in the fields of energy (electricity and gas), climate, competition and/or defence
1-3 years' experience in a similar position
Excellent knowledge of the English language
Ability to work with tight deadlines according to the organizational needs
High professionalism and great attention to detail are essential
Excellent communication and interpersonal skills
Strong research and analytical skills

Job Responsibility

Actively monitors EU policy and regulatory developments in areas of relevance to METLEN (energy, climate, industrial policy, competition, taxation, environmental matters, trade, funding, defence etc.)
Advises the European Affairs & Regulatory Advocacy Division on all matters relating to EU regulation
Supports the European Affairs & Regulatory Advocacy Division in public affairs activities in Brussels, including drafting contributions to public consultations, attending debates, workshops and conferences, and interacting with EU policymakers and other relevant stakeholders
Actively contributes to activities organized by trade associations in which METLEN is a member, including attending meetings and contributing to the drafting of position papers
Prepares policy briefs, email updates and presentations related to the latest EU policy developments

Fulltime

Regulatory Affairs Associate

CK Group

Location:
United Kingdom , Reading

Category:
Pharmacy

Contract Type:
Contract work

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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