Thermo Fisher Scientific Invites Job Applications
POSITION: Reg Affairs Manager
Job Description
At Thermo Fisher Scientific, you will find important work that has a positive global influence. Join our colleagues in bringing our Mission to life by empowering our customers to make the world healthier, cleaner, and safer. We equip our staff with the resources they need to realize their particular professional goals, while also pushing science forward via research, development, and delivery of life-changing therapies.
With clinical trials completed in over 100 countries and the continual development of fresh frameworks for clinical research through our PPD clinical research portfolio, we provide laboratory, digital, and decentralized clinical trial services. Your commitment to delivering quality and accuracy will enhance health outcomes that people and communities rely on, both now and in the future.
We are now looking for a Regulatory Affairs Manager to join our worldwide Regulatory Affairs department, Regulatory Science team. This is an excellent opportunity to advance your regulatory career and skills within a global clinical trial context.
Responsibilities:
- Lead the preparation of global regulatory submissions while maintaining high-quality standards that fulfill local and regional requirements.
- As a subject matter expert, provide regulatory strategy guidance and technical experience to internal and external clients, as well as major client projects with moderate to high complexity.
- Provides internal clients with current legislation and guidance as it becomes available.
- Ensure quality performance on key/managed projects.
- Manage the project budgeting and forecasting functions.
- Identify and recognize out-of-scope operations in a contract in a timely manner, and coordinate with other departments to carry out all parts of contract revisions.
- Collaborate with business development to price and secure new business by giving client presentations and generating proposal texts and budgets in coordination with other departments.
- Provides matrix/project leadership, training, and advice to junior team members.
- Maintain compliance with relevant organizational and regulatory SOPs and WPDs.
- Attend launch meetings, reviews, and project team meetings.
Qualifications – External
What you’ll need for the role:
- A bachelor’s or advanced degree is preferred, or an equivalent and related formal academic/vocational certification.
- At least 5 years of previous experience providing the knowledge, skills, and abilities required to do the job.
- Proven project management expertise and excellent performance in a client-facing capacity.
Knowledge, Skills, and Ability:
- Exceptional communication skills in English and local language, with strong attention to detail and proofreading abilities.
- Exceptional interpersonal abilities for working well in a team environment and acting as a liaison with other departments.
- Advanced computer skills, including the use of Microsoft Word, Excel, and PowerPoint; capable of learning new technologies.
- Strong organizational, time management, and planning ability to set and follow timetables, undertake long-term planning, adjust to changing priorities, and manage various projects.
Excellent negotiating skills
- Capable of working independently and using independent judgment to assess sponsor regulatory needs and collaborate with project team members to provide compliant deliverables.
- Excellent awareness of global, regional, and national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management; expert knowledge of ICH and other worldwide regulatory guidelines.
- Excellent analytical, investigative, and problem-solving abilities.
- Excellent understanding of budgeting and forecasting.
What we offer:
We provide competitive salaries and a comprehensive benefits package that prioritizes employee health and well-being. We have a flexible working environment, and PPD Clinical Research Services places a high importance on work-life balance. Also, We’ve grown steadily year after year while maintaining a collaborative environment, with teams of colleagues eager to share skills and have fun together. We are a worldwide organisation with a local feel.
Our mission is to help our clients make the world healthier, cleaner, and safer. Watch our colleagues discuss five reasons to collaborate with us. As a team of 100,000+ people, we share a set of principles – Integrity, Intensity, Innovation, and Involvement – and collaborate to expedite research, solve complex scientific challenges, drive technology innovation, and assist patients in need.
How to Apply for this Thermo Fisher Scientific Job
Closing Date: December 17, 2024
NOTE:
It is important to keep in mind that employers receive many applications for each job posting and will only select the most qualified candidates. Furthermore, NewsNowGh does not have any influence over the decisions made by employers/recruiters. As a result, we cannot guarantee that sending applications will lead to candidates being shortlisted or selected for a particular position.
RECOMMENDED
- FIRSTLY, MASSIVE JOB RECRUITMENT AT LMI HOLDINGS
- SECONDLY, THE JOB ADVERTISEMENT AT STERLING INTERNATIONAL SCHOOL
- THIRDLY, JOB OPENING AT CUMMINS AFRICA MIDDLE EAST
- MOREOVER, PWC CAREERS AFRICA INVITES JOB APPLICATIONS
- FURTHERMORE, MASSIVE JOB RECRUITMENT AT GHANA CHRISTIAN INTERNATIONAL HIGH SCHOOL
- THEN, JOB OPENING AT COMPETENCY SCHOOL OF BUSINESS ADMINISTRATION
- ALSO, JOB ADVERTISEMENT AT WEST AFRICA CIVIL SOCIETY INSTITUTE (WACSI)
- ADDITIONALLY, JOB VACANCY AT KINTAMPO HEALTH RESEARCH CENTRE (KHRC)
- AFTERWARD, EXCITING CAREER OPPORTUNITY AT ABSA BANK
- FINALLY, JOB OPENING AT GIU INTERNATIONAL CHRISTIAN