Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Publishing/Submissions - Home Based EMEA
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.
As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist, you will electronically publish regulatory documents and submissions via electronic gateways using submission publishing tools. Seeking candidates with experience using Adobe Acrobat, Adobe Acrobat Plug Ins and other submission publishing tools.
Provides strategic, expedient and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in a technical quality review role and is responsible for the thorough review of published documents and submissions created within or outside of PPD to ensure quality of standards meet regulatory compliance requirements and meet or exceed client expectations.
Provides client electronic submission deliverables supporting regulatory compliance
Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and data security issues
Maintains document lifecycle for submissions
Supports development and implementation of project-specific processes for sponsors with unique technology requirements and may act as the PPD liaison for regulatory submission with the sponsor and assist PPD project teams in executing regulatory submission strategies
Provides mentoring of other regulatory publishing personnel, as needed
Uses professional judgment to evaluate the regulatory publishing needs in relationship to the overall project timelines, quality and delivery
Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or risk to delivery
Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).
Knowledge, Skills and Abilities:
Working knowledge of global regulatory requirements and guidances for submission requirements, document management, document publishing and electronic submissions
Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools
Advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates
Ability to manage several complex projects in parallel and adapt to changing priorities
Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices
Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables
Ability to independently learn new technologies
Excellent organizational skills and effective interpersonal skills
Excellent analytical ability and problem-solving capabilities
Good working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies
Excellent editorial/proofreading skills
Detail-oriented, thorough, and methodical
Ability to create and follow timelines and conduct long-range planning
Ability to multi task performing numerous single or complex tasks without ignoring overall objectives
Ability to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers’ comments
Ability to concentrate on the detail in a document without losing sight of the document as a whole
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.