Regulatory Affairs Specialist CTA (Clinical Research Field)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Location/Division Specific Information

(Currently is seeking a Senior/Regulatory Affairs Specialist to join our growing Regulatory Affairs department - Regulatory science team. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field.

Regulatory Affairs Specialist - CTA (Clinical Research Field)

In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.

Youll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted interacting with sponsors review and assess clinical trial regulatory documents review and assess scientific literature. You will also act as primary point of contact for the sponsors of assigned projects.

Responsibilities:

• Supports the preparation of documentation and CTA submissions under guidance.
• Coordinates and manages client deliverables supporting regulatory compliance.
• Liaises with internal and external clients in the tracking and status update of
  project plans and overall support of projects.
• Assists with projectbudgeting/forecasting.
• Maintains knowledge and understanding of SOPs client SOPs/directives andcurrent regulatory guidelines.
• Assists in business development and pricing of projects for the department.
  Evaluates client needs in relationship to overall project timelines quality
• anddelivery.
• Engages other project team members functional units and/or management asnecessary to deliver final product and resolve/mitigate identified issues orbarriers to delivery as needed.

What the role requires you to have:

• Bachelors degree or advanced degree preferred or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job of at least 2 years
• Experience with regulatory submissions
• Knowledge of the global clinical trials landscape
• Proven project management experience and experience performing effectively in a client facing role

Knowledge Skills and Abilities:

• Excellent command of the English language (written and oral) as well as local language where applicable
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word Excel Power Point; capable of learning new technologies
• Strong organizational time management and planning skills to create and follow timelines conduct long-range planning adapt to changing priorities and handle multiple projects
• Excellent negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
• Excellent analytical investigative and problem-solving skills
• Understanding of budgeting and forecasting

What we offer:

As well as being rewarded a competitive salary we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture where PPD Clinical Research Services truly value a work-life balance. Weve grown sustainably year on year but continue to offer a collaborative environment with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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