Regulatory Affairs Manager Clinical Trial Applications

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.

We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department Reg Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.

You will be part of a global team providing innovative regulatory solutions owning regulatory affairs responsibilities and leading discussions with internal and external clients.

You will also be coordinating global regulatory strategies on assigned (Phase 1 to 4) clinical trials studies and projects and providing the technical/ project leadership across regions supporting our clients with strategic regulatory intelligence and guidance for the product development mainly during the clinical phases.

The role also supports and leads the preparation of client deliverables that meet current local regional and ICH regulatory and technical requirements also acts as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments supporting business development working on initiatives and contributing to quality improvement. You will also arrange lead and report on client and regulatory agency meetings.

Responsibilities:

• Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements.
• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.
• Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensure quality performance for key/managed projects.
• Manage project budgeting/forecasting functions.
• Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications.
• Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments.
• Provides matrix/project leadership training and guidance to junior team members.
• Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
• Participate in launch meetings review meetings and project team meetings.

Qualifications - External

• 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 at least 5 years.
• Proven project management experience and experience performing effectively in a client facing role

Knowledge Skills and Abilities:

• Excellent English language (written and oral) communication skills 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 licensing lifecycle management; expert knowledge of ICH and other global regulatory guidelines;
• Excellent analytical investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting

What we offer:

At PPD Clinical Research Services we hire the best develop ourselves and each other and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career and therefore at PPD you will benefit from an award-winning learning and development programme ensuring you reach your potential.

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.