Current jobs related to Dir, Regulatory Consulting - Remote - Syneos Health Clinical

  • Regulatory Consultant

    7 days ago

    Remote, United Kingdom Amentum Full time

    We'll inspire and empower you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow. We offer an exciting range of opportunities to develop your career within a supportive and diverse team who always strive to do the right thing for our people, clients and communities.People are our greatest asset, and we offer a...

  • Senior Regulatory Economist

    1 week ago

    Remote, United Kingdom Public Sector Resourcing Full time

    **Senior Regulatory Economist - **Inside IR35** **Contract Term: 12 Months** **Contracting Authority: Network Rail** **Location: Remote (Once a month in London)** **As a Senior Regulatory Economist, your main responsibilities would be**: - Manage industry responses to our upcoming Access Charges consultation, providing insight into how to address any...

  • Senior Regulatory Advisor

    1 week ago

    Remote, United Kingdom SGS Full time

    SGS are currently looking for a Senior Regulatory Advisor to manage clients within the UK food industry. Home based role **Main Purpose of the Role**: - To provide a high level of professional services to key retail clients. - Responsible for ensuring that products are safe and legal by providing consultancy for legal and technical compliance,...

  • Regulatory & Compliance Officer

    4 days ago

    Remote, United Kingdom Office Zebra Ltd Full time

    **Our client are a Global household name who are seeking to add to their existing team. The workplace is one of innovation, collaboration, and teamwork. The environment is welcoming and rich in talent, backgrounds, and cultures. They empower their people to be the best they can be and see uniqueness as a key asset to their community.** **With a fantastic...

  • Regulatory Advisor

    19 hours ago

    Remote, United Kingdom Campden BRI Full time

    ***£34,000-£38,000 pa based on experience** *** ***+ Employee benefits**: ***Remote working**: **Consulting Technology**: Supporting food manufacturers and retailers with product innovation including: rheology, new product development, value optimisation, instructional development, pilot plant, quality and food safety manufacturing, thermal processing,...

  • Industrial Safety Consultant

    2 weeks ago

    Remote, United Kingdom Finch Consulting Limited Full time

    The OpportunityAs a Consultant / Expert Witness in Industrial Safety, you will combine strategic safety leadership, consultancy and expert witness development. You will:Lead complex safety consultancy projects across diverse high-hazard sectors.Provide authoritative advice on CDM compliance, risk assessment, audits, and safety management systems.Develop...

  • Senior Regulatory Affairs Consultant

    3 days ago

    United Kingdom-Harrow-Remote Parexel Full time

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Biostatistician

    2 weeks ago

    Remote, United Kingdom OCS Consulting Full time

    **Biostatistician - Contract - 6 months initial contract - Hybrid/Netherlands** We are a prestigious Life Sciences Consultancy with a powerful and successful consultancy base, seeking for a highly skilled and experienced biostatistician to join our team as a contractor. The contractor statistician will be responsible for providing statistical support for...

  • TSYS Consultant

    1 week ago

    Remote, United Kingdom Akkoda Full time

    TSYS Consultant – Cards Migration ProjectLocation: LondonContract Type: Contract (Outside IR35)Reports to: Programme Manager, Cards Migration / Payments Transformation LeadAbout the RoleWe are seeking an experienced TSYS Consultant to support a large-scale cards migration program following the merger of two major banking organizations. The successful...

  • Principal Consultant

    1 week ago

    Remote, United Kingdom ixceed Full time

    Role: Principal Consultant (Oracle Fusion Cloud Planning)Location: Remote, UKMode: RemoteType: ContractJob Description:About the RoleWe are seeking a seasoned Functional Lead to drive the implementation of Oracle Fusion Cloud Planning modules — including Supply Planning, Demand Planning, Global Order Promising (GOP), and Sales & Operations Planning...

Dir, Regulatory Consulting

2 weeks ago

Remote, United Kingdom Syneos Health Clinical Full time

**Description**

**Director, Regulatory Consulting**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Provides strategic and tactical regulatory guidance relating to global drug development.
- Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
- Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents. Reviews and approves guidelines for document preparation. Ensures regulatory documents are accurate and current.
- Leads and attends project staff meetings, project team meetings and training sessions.
- Provides timely, accurate information to business management staff regarding hours to be budgeted for assigned regulatory tasks for Requests-for-Proposal (RFP). Reviews RFPs and budgeted hours for regulatory deliverables and forwards issues to the Project Manager or Functional Manager. Periodically reviews project expenditures for compliance with budgets for assigned tasks.
- Interacts directly with customers and potential customers to explain regulations surrounding assigned regulatory functions; reviews processes and factors affecting project cost estimates.
- Contributes to regulatory affairs process improvement efforts. Leads meetings to discuss current and future activities of the department.
- Maintains overall awareness in the field of drug development, as well as applicable regulatory requirements, by reading related literature, attending training classes, attending professional meetings, etc. Conducts Continuing Education sessions, presenting information gathered from off-site conferences to coworkers.

**Qualifications**

**What we’re looking for**
- BS degree in the science/health care field or equivalent combined education and experience. MD or PhD preferred.
- Extensive regulatory experience and significant supervisory and/or project management experience.
- Demonstrated expertise in at least one area of product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development.
- Experience/familiarity with document preparation and regulatory submission strategies preferred.
- Knowledge of procedures for overall drug development procedures.
- Extensive knowledge of Regional regulatory guidance, regulations and terminology.
- Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Ability to coach and develop others, and to act as a catalyst for positive change.

**Get to know Syneos Health**
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

**Additional Information**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign