Principal Reg Affairs Specialist

7 months ago

Remote, United Kingdom Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll 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.Our Global Regulatory Affairs team is expanding We are looking for a Principal Regulatory Affairs Specialist position to work for one of our key clients.

This a client dedicated role for a Regulatory Affairs Sr Specialist role: clinical expert role to support clinical trial new indications, including the early indications, early development and late development, and that can support later development. Global experience is a plus, EU CTR experience will be important.

The Principal Reg Affairs Specialist will act as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. They will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. They will also act as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions:

- Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.
- Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services.
- Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables.
- May provide input on performance reviews to management.
- Ensures adherence to project budgets, time schedules, and scope of work.
- Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
- Contributes to business development activities, including project budgeting/forecasting.

Qualifications:
Education and Experience:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

- Excellent English language (written and oral) communication skills as well as local language where applicable
- Great attention to detail and quality as well as excellent editorial/proofreading skills
- Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Strong computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Strong 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
- Strong 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; good understanding of a regulatory speciality areas, clinical, in particular Clinical Trial Applications (CTA) including proven experience in submissions according to EU Clinical Trial Regulation.
- Experience in Global CTAs would be an advantage.
- Strong understanding of medical terminology, statistical concepts, and guidelines
- Excellent analytical, investigative and problem-solving skills
- Solid 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 hea

  • Medical Affairs Specialist

    4 days ago

    Remote, United Kingdom CK Group Full time £39 - £52

    Role OverviewCK Group is recruiting for a Medical Affairs Advisor to join a leading pharmaceutical company in the UK, working remotely on a contract basis. This exciting opportunity offers a unique chance to provide medical and scientific advice to healthcare professionals and professional bodies.

  • Medical Affairs Advisor

    1 week ago

    Remote, United Kingdom CK Group Full time €39 - €51

    CK Group are recruiting for a Medical Affairs Advisor, to join a company in the pharmaceutical industry, working remotely, on a contract basis for 6 months. Salary: PAYE £38.98 p/h to £51.97 p/h. Umbrella £43.68 p/h to £58.24 p/h. Role: To provide medical and scientific advice to healthcare professionals and professional bodies, through...

  • Medical Affairs Advisor

    1 week ago

    Remote, United Kingdom CK Group Full time €39 - €52

    CK Group are recruiting for a Medical Affairs Advisor, to join a company in the pharmaceutical industry, working remotely, on a contract basis for 6 months.   Salary: PAYE £38.98 p/h to £51.97 p/h. Umbrella £43.68 p/h to £58.24 p/h. Role: To provide medical and scientific advice to healthcare professionals and professional bodies through...

  • Regulatory Affairs Advisor

    4 days ago

    Remote, United Kingdom CK Group Full time £39 - £52

    About the Role:As a Medical Affairs Advisor at CK Group, you will play a vital role in providing medical and scientific advice to healthcare professionals. This contract-based position offers an exciting opportunity to work in the pharmaceutical industry and contribute to the discovery, development, and provision of medicines.Responsibilities:Provide...

  • Medical Affairs Consultant

    4 days ago

    Remote, United Kingdom CK Group Full time £39 - £52

    Overview:CK Group is seeking a highly skilled Medical Affairs Advisor to join their team in the pharmaceutical industry. This contract-based role offers an excellent opportunity for professionals to provide medical and scientific advice to healthcare professionals and promote the appropriate use of medicines.Job Description:The successful candidate will be...

  • Principal Consultant

    6 months ago

    Remote, United Kingdom Towergate Health & Protection Full time

    **Principal Consultant - Remote (South London) - ARD928579** - Car allowance included._ **Are you an experienced PMI Consultant from a broking background with senior field-based experience?** We have an exciting opportunity for a Principal Consultant to join our team working remotely with our clients based in and around South London. As a Principal...

  • Principal Biostatistician

    7 months ago

    Remote, United Kingdom Syneos Health Clinical Full time

    **Description** **Principal Biostatistician (Remote - Targeting UK, Ireland, Mexico, or Argentina)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...

  • Principal Biostatistician

    6 months ago

    Remote, United Kingdom Syneos - Clinical and Corporate - Prod Full time

    **Description** **Biostatistician II- Sr Principal Title Available (Remote Role - Targeting the following Countries only: UK, Ireland, South Africa, Spain, Romania, Serbia, Greece, Croatia, Poland, C.R, Hungary, Portugal, Bulgaria, Slovakia, Slovenia, Egypt, Turkey, Cyprus, Mexico, Colombia, Chile, Brazil, Argentina)** **Principal Biostatistician** Syneos...

  • Principal Support Specialist

    6 months ago

    Remote, United Kingdom Open Text Corporation Full time

    **Principal Support Specialist - Extream/Streamserve**: - Req id: 40807- Virtual, GB Hoofddorp, NL Virtual, IE Reading, GB Virtual, IT Newbury, GB Virtual, BE Cork, IE**OPENTEXT** OpenText is a global leader in information management, where innovation, creativity, and collaboration are the key components of our corporate culture. As a member of our team,...

  • Scientific Communications Specialist

    4 days ago

    Remote, United Kingdom CK Group Full time £39 - £52

    Job Summary:CK Group is recruiting a Medical Affairs Advisor to work remotely on a contract basis. This role involves providing medical and scientific advice to healthcare professionals and promoting the appropriate use of medicines.Key Responsibilities:Provide specialist medical, scientific, and Code compliance advice to internal teamsLiaise with healthcare...

  • Principal / Senior Biostatistician - Fsp Model

    6 months ago

    Remote, United Kingdom Syneos - Clinical and Corporate - Prod Full time

    **Description** **Principal or Senior Biostatistician - Full time permanent, home based, FSP model** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...

  • Principal Biostatistician- R Shiny Experience

    6 months ago

    Remote, United Kingdom Syneos - Clinical and Corporate - Prod Full time

    **Description** **Principal Biostatistician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Appeals, Overpayments

    6 months ago

    Remote, United Kingdom Business Smart Solutions Full time

    **Rate**:£29.56 per hour (umbrella) **Term**:12 Weeks **Hours per week**: 36 **Location**: Remote To develop and deliver specialist support/advice to a Housing Benefit/Council Tax Reduction processing or Housing Benefit overpayment teams. To ensure relevant legislation, regulations and policies are complied with. To monitor and allocate incoming work and to...

  • Health Adviser

    1 week ago

    Remote, United Kingdom CK Group Full time €39 - €51

    CK Group are recruiting for a Medical Affairs Advisor, to join a company in the pharmaceutical industry, working remotely, on a contract basis for 6 months. PAYE £38.To provide medical and scientific advice to healthcare professionals and professional bodies, through scientific communications and assistance for clinical research, to facilitate a...

  • Health Adviser

    1 week ago

    Remote, United Kingdom CK Group Full time €39 - €52

    CK Group are recruiting for a Medical Affairs Advisor, to join a company in the pharmaceutical industry, working remotely, on a contract basis for 6 months.   PAYE £38.To provide medical and scientific advice to healthcare professionals and professional bodies through scientific communications and assistance for clinical research to facilitate...

  • Fungal Infection Specialist Medical Advisor

    2 weeks ago

    Remote, United Kingdom Mundipharma Full time

    About MundipharmaMundipharma is a global healthcare company dedicated to bringing innovative treatments to patients in areas such as Pain Management, Infectious Disease, and Consumer Healthcare.Job OverviewWe are seeking a Fungal Infection Specialist Medical Advisor to join our team. This role will play a crucial part in driving the success of Rezafungin in...

  • Specialist Ii, Training

    6 months ago

    Remote, United Kingdom Payroc Full time

    Specialist II, Training & QA **Reports To** Manager, Training & QA **Job Purpose** This Role provides coaching, training and support to all inbound and outbound support specialists who are interacting with our merchants. Showcase that you have an understanding that our merchants' success is also our success. Working with specialists, leads and others to...

  • Senior Director, Medical Information

    1 month ago

    US - Remote - East Coast, UK, United Kingdom myGwork Full time

    This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Role Summary Autolus Therapeutics is seeking a dynamic and experienced Senior Director of Medical Information to lead the development and execution...

  • Technical Support Specialist I, Terminal

    6 months ago

    Remote, United Kingdom Payroc Full time

    **Job **Description** Technical Support Specialist I, Terminal **Reports **To** M anager, Technical Support, Operations. **Job **Purpose** In this role you will be the initial p oint of contact for our merchants as a part of the Payroc Terminal Support Team. You work work with merchants to solve all of their technical inquiries as well as coach them to...

  • Principal Safety Specialist

    7 months ago

    Remote, United Kingdom Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll 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...