Regulatory Affairs Advisor Job at Boots (Nottingham)

Manager, Regulatory Affairs Advertising & Promotion

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
Demonstrated ability to independently review promotional materials and make sound regulatory decisions
Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
Excellent communication, influence, and stakeholder management skills
Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset

Job Responsibility

Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)
Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders

What we offer

Flexibility of remote work

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

EU Affairs Advisor

The EU Affairs Advisor supports Vodafone's Brussels-based engagement by tracking...

Location

Belgium , Brussels

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Strong understanding of EU policy-making processes and institutions, with experience tracking files and engaging stakeholders
Ability to turn complex policy developments into concise, actionable advice for senior and non-specialist audiences
Drafting skills: briefings, speaking notes, position papers and consultation responses, with attention to evidence and narrative
Stakeholder management and coalition-building skills across trade associations, NGOs, think tanks and peer companies
Knowledge of telecoms and digital policy issues (connectivity investment, spectrum, competition, cybersecurity, digital platforms and AI) is an advantage
Bachelor's degree (or equivalent) in European studies, political science, law, economics, international relations or similar
Experience in EU public affairs/public policy (e.g., industry, consultancy, trade association, EU institution), typically 3+ years

Job Responsibility

Monitor and analyse EU legislative and regulatory developments affecting Vodafone (e.g., connectivity, digital markets, cybersecurity, data, sustainability), translating implications into clear internal advice
Support engagement with EU institutions and stakeholders (European Commission, European Parliament, Council, Permanent Representations, regulators, industry associations), including briefings, meeting preparation and follow-up
Contribute to the development of Vodafone policy positions, consultation responses and advocacy materials, ensuring consistency with Group strategy and evidence-based messaging
Coordinate across Group functions and operating companies to gather inputs, align priorities and maintain a single narrative for EU engagement and external communications
Maintain stakeholder and policy intelligence (contact mapping, trackers, briefings, Q&A and data banks) and help deliver events, roundtables and coalition activity in Brussels and key EU capitals

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Senior Regulatory Affairs Specialist

Are you interested in the future of digital health and medical device innovation...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Master’s degree within natural sciences, computer science, engineering or similar
5-10+ years in regulatory affairs (preferably both software and hardware medical devices)
Global regulatory market experience (e.g. EU, UK, Switzerland and MDSAP)
Demonstrated experience applying and interpreting relevant guidance and standards across software and hardware medical devices, including: IEC 60601 series, ISO 14971, IEC 62304, IEC 82304
Strong knowledge of cybersecurity and the evolving regulations for digital health and AI/ML devices
Adaptable and open to change and adjustments in agile work environments
Global mindset and experience with work relations in different cultures

Job Responsibility

Ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices
Involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices
Ensuring global device registrations
Working closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants
Active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks

What we offer

An attractive healthcare package to keep you fit and well
Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
Good work/life balance e.g., work from home policy for up to 2 days per week
Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
Social clubs, monthly Friday social activities, as well as various in-team activities

Fulltime

Senior Medical Affairs Advisor, Vaccines

Reporting to the Medical Director, you will provide scientific and medical suppo...

Location

Hong Kong , Quarry Bay

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in pharmacy, pharmacology or other relevant disciplines
Professional experience in hospitals, research or pharmaceutical industry is desirable
Project and process management: ability to manage projects and cross-functional Processes
Administrative excellence: attention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.
Organizational skills and able to work independently
Fluent spoken and written English and Chinese

Job Responsibility

Develop, lead and execute the medical strategy, tactics, and operating plan at country level for Vaccines portfolio that fully aligned with the Global, Regional and Local overall strategy goals
Prepare new product launch by generating medical insights and understand the unmet medical needs through medical-to-medical communication, advisory board and data generation
Manage investigator-initiated trial including discussion of research concept with interested researcher, coordinate internal submission and approval of study protocol, and act as a liaison between Pfizer and the researcher
Review promotional materials and customer engagement programs for scientific accuracy and adherence to the relevant policies, guidelines, local industry codes and regulatory guidelines as required
Provide disease and product training to sales and marketing colleagues when required
Establish partnership with patient organizations, professional organizations, medical societies to understand the unmet medical needs. Identify potential ways to address them with an aim to improve patients’ outcomes
Organize medical meetings and activities with KOLs to deliver cutting edge medical information of defined therapeutic area and assigned products
Conduct medical educational meetings to introduce new concepts to help HCPs to improve patients’ outcome and advance their research capability
May speak at medical communication meetings at national and regional levels

Fulltime

Senior Manager, Central Regulatory Affairs

The Sr. Manager - Central RA is a pivotal senior leadership role based out of Ba...

Location

India , Bangalore

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related discipline
12+ years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with significant people management and team development
Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals
Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders
Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives

Job Responsibility

Develop and implement global regulatory strategies for Baxter products (both Drugs and Devices) aligned with business objectives to support product lifecycle spanning timely Initial /Geo-expansion/ Change controls and Variations registrations enabling speedy commercialization across diverse markets
Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements
Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions
Lead the preparation and submission of regulatory documents, including lifecycle management submissions, to regulatory authorities globally
Ensure that all submissions are accurate, complete, and compliant with regulatory requirements
Engage and collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to gather necessary information and ensure alignment
Oversee the preparation, review, and submission of both Drug and Device Lifecycle management regulatory filings (e.g., Initial and Geo-expansion registrations, change controls, Variations, Tender support, Acquisition Integration /Divestiture related Legal Entity name changes etc.) to health authorities across global markets
Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions
Establish and maintain standardized regulatory processes, procedures, and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA
Generate future readiness with implementation of best practices and continuous improvement initiatives to optimize regulatory operations and ensure consistency across regions for registrations, Change Control Management, tender Support, Geo-expansion/Initial registrations

Vice President, Regulatory Affairs

Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, or equivalent preferred)
15+ years of regulatory affairs experience in biopharmaceuticals from pre-clinical to commercialization, with at least 8 years in leadership roles
Experience in cell and gene therapy field is preferred
Proven track record of successful IND and BLA submissions (prior BLA experience required)
Deep knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks
Strong leadership, strategic thinking, and negotiation skills
Excellent communication and stakeholder management abilities
Strong team orientation and passion for continuous self-development

Job Responsibility

Develop and implement global regulatory strategies for cell therapy programs across clinical development, manufacturing, and commercialization
Serve as the primary regulatory advisor to executive leadership, ensuring alignment with corporate objectives and regulatory requirements
Anticipate and interpret evolving regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP frameworks
Assess and communicate potential regulatory risks and propose mitigation plans
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
Oversee content preparation and submission of INDs, CTAS, and BLAs/MAAs, and other relevant submissions to regulatory agencies
Lead strategy for global expedited pathways (e.g. RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US and EU), where applicable
Ensure compliance of programs and submission documentation for adherence to GxP, ICH, and regional regulatory requirements throughout development and manufacturing
Build and maintain strong relationships with FDA CBER and other regulatory agencies and represent the company in key regulatory meetings and negotiations
Ensure timely and high-quality responses to health authority inquiries, including pre-BLA meetings, Type B/C/D meetings, and scientific advice

What we offer

health and retirement
PTO
stock option plans

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