Senior Regulatory Affairs Consultant

Regulatory Affairs Senior Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

United States

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 3-5 years’ experience in Regulatory Affairs
or equivalent combination of education and experience
Experience working in the pharmaceutical industry
Ability to prioritize and drive multiple projects
Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines
Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA
Ability to maintain confidentiality and responsive to client needs
Ability to adapt under regularly changing conditions

Job Responsibility

Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients
Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications
Drafts and manages regulatory submissions
Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files
Coordinates regulatory fee payments on behalf of client
Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence)
Liaises with regulatory authorities on behalf of clients (e.g., US Agent)
Builds, develops and maintains working relationships with clients
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner
Performs basic document management tasks including file transfer, storage, tracking, and archival

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime

Senior Manager, Regulatory Affairs

Location

India , Thane

Salary:

Not provided

Cencora

Expiration Date

June 30, 2026

Requirements

Expert in Regulatory submissions in India
Minimum 12 years experience
Ability to translate strategical goals into tactical goals
Structured, analytical, systematic and independent way of working
Lead extensive project reengineering activities
Demonstrable ability in leading, mentoring, managing and motivation of staff
Ability to lead project teams
Ability to manage internal and external (client) relationships
Very good communication skills (written and verbally)
English business fluent

Job Responsibility

Develop and maintain strong client relationships
Participation in regulatory processes to gain and maintain marketing authorizations
Preparation, review and compilation of documents within the framework of regulatory affairs projects
Communication with clients and Health Authorities
Support with scientific advice procedures and representation of clients
Responsible for the planning and execution of client projects
Coordination of project teams
General guidance (consultancy) regarding Regulatory Strategy and Procedure Management
Regulatory intelligence
Present seminars and lectures

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen; Brussels

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

New

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

Head of Regulatory Affairs

The Head of Regulatory Affairs manages a central team that connects regulatory i...

Location

United Kingdom

Salary:

Not provided

Campden BRI

Expiration Date

Until further notice

Requirements

Degree qualified in a relevant subject, with extensive experience in food law
Extensive experience in regulatory affairs, regulatory intelligence, policy interpretation, or an equivalent field, ideally within food, beverage, or other regulated sectors
Proven track record as a recognised expert in regulatory matters, built through sustained delivery, external engagement and peer or client recognition
Experience leading teams or functions, including people development, performance management and capability building
Demonstrated experience in consultancy or advisory settings, working directly with clients on regulatory, compliance or market‑access challenges
Experience proof reading and/or producing high‑quality, insight‑driven outputs, such as regulatory summaries, impact assessments, horizon scans, or technical briefings
Highly developed analytical, interpretive, and critical‑thinking skills, with the ability to synthesise large volumes of technical, legislative or policy material into accurate, actionable insights
Innovative problem‑solving skills, able to generate new ideas and translate them into workable solutions within a multidisciplinary environment
Excellent written and verbal communication skills, producing authoritative guidance, reports and recommendations tailored for technical, commercial, and senior‑leadership audiences
Confident presenter, capable of representing Campden BRI at external events, client forums, conferences, and technical platforms

Job Responsibility

Strategic Regulatory Leadership
Cross‑Organisational Collaboration & Solution Development
Financial & Operational Leadership
People Leadership & Capability Development
Thought Leadership & Market Differentiation
Client Relationship Management & Strategic Partnering

What we offer

Reward platform with employee discounts and rewards
25 days holiday + 8 bank holidays
Buy and sell holiday scheme
A generous work save pension scheme, with employee contributions matched by the company up to 10%
Culture focus around work/life balance (early finish Fridays)
Subsidised onsite restaurant

Fulltime

External Public Affairs Manager

The External Public Affairs Lead will manage the organisation’s public policy, l...

Location

United Kingdom

Salary:

Not provided

Campden BRI

Expiration Date

Until further notice

Requirements

Degree qualified in public policy, law, political science, economics, international relations, or a relevant scientific/regulatory discipline
A postgraduate qualification (e.g., Masters) in a relevant field is an advantage
Extensive experience 5 yrs + working in government affairs, public policy, regulatory strategy, or a related senior‑level external affairs role, ideally within the food, drink, science, or consumer goods sectors
Demonstrated credibility when engaging with senior government officials, regulators, policy advisers, and industry bodies, with a strong understanding of UK and EU policy‑making processes
Strong capability to interpret, analyse and communicate complex legislation, regulatory developments, and political trends
Experience developing policy positions, consultation responses, strategic briefings, and evidence-based advocacy materials
Skilled at developing and executing advocacy strategies that influence government policy and regulatory frameworks
Strong stakeholder management skills with the ability to build trusted relationships across government, industry, members/clients, and internal teams
Proven ability to lead multi-stakeholder projects, influence outcomes, and navigate political and regulatory environments
Effective project and programme management experience, including coordination of cross-functional teams

Job Responsibility

Lead the development and implementation of the organisation’s government affairs strategy, ensuring alignment with business priorities and industry needs
Monitor, assess and communicate emerging legislation, policy reforms and regulatory developments across UK, EU, and global markets
Advise senior leadership on risks, opportunities, and the strategic implications of policy trends
Build and maintain influential relationships with government departments, regulatory authorities, parliamentarians, policy advisers, and public sector stakeholders
Represent the organisation externally, positioning it as a trusted expert voice in food, drink, and consumer goods policy
Participate in consultations, policy reviews, advisory groups, and public hearings
Oversee political monitoring processes and ensure timely, accurate intelligence flows into the organisation
Prepare regular reports, risk analyses, and strategic updates for senior leadership teams
Support training and capability‑building across the business on policy engagement and government interface
Develop some evidence-based advocacy materials, including position papers, briefings, consultation responses, and speeches

What we offer

Reward platform with employee discounts and rewards
25 days holiday + 8 bank holidays
Buy and sell holiday scheme
A generous work save pension scheme, with employee contributions matched by the company up to 10%
Culture focus around work/life balance (early finish Fridays)
Subsidised onsite restaurant

Fulltime

Senior Government Affairs Manager

We’re looking for a European Government Affairs Lead to drive our strategy and e...

Location

Germany

Salary:

Not provided

Wiz

Expiration Date

Until further notice

Requirements

10+ years of experience in advocacy or public policy/government affairs, including a breadth of experience across government, military, consulting, thought leadership and/or prior in-house roles
Strong familiarity with emerging technology public policy trends in the areas of cybersecurity, cloud, cross-border data flow and digital trade, competition, artificial intelligence and public sector procurement
Excellent verbal and written communication skills, including the ability to articulate complex regulatory and policy matters into easily understood language
Excellent interpersonal and negotiation skills
Strong government contacts
Strong analytical and problem-solving skills
Applicants must have the legal right to work in the country where the position is based, without the need for visa sponsorship

Job Responsibility

Support the continued growth and maturity of our government affairs program, with a focus on educating EU and UK policymakers, crafting a favorable regulatory environment and providing support to market development
Pro-actively identify the need for (and lead the development of) government affairs products for both internal and external consumption
Support the Government Affairs team in advising Wiz leadership on policy developments, challenges and opportunities, including both tactical and long-term strategic planning
Build and maintain key professional relationships with decisionmakers across the EU, its member countries, and the United Kingdom
Support our work with consultants and industry associations in pursuit of effective policy outcomes
Manage engagement with third-party influencers in the policy environment, including think tanks, civil society groups, philanthropies and other bodies in support of Wiz priorities
Publish and speak publicly and on the record on behalf of Wiz
Develop close working relationships with teams across Wiz, including legal, compliance, standards, security, product, finance, communications, sales and sustainability
Perform other duties as required

Senior Regulatory Affairs Consultant - Regulatory Intelligence

Parexel

Location:
United States , Remote

Category:
Consulting

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 16, 2026

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