Regulatory Affairs Strategist
4 weeks ago
Parexel is seeking a Regulatory AffairsStrategist (Regulatory Affairs Consultant) with extensive experience in EU, US, and ROW markets. As a Regulatory Strategist, you will play a crucial role in providing regulatory representation in cross-functional teams, developing regulatory strategies, and advising on regulatory expectations, requirements, and timelines. This is a client dedicated project. This role can be home or office based in various European locations.
Responsibilities:- Develop and implement regulatory strategies for global submissions in accordance with applicable regulations.
- Prepare, maintain, and coordinate regulatory submissions including INDs, CTAs, NDAs, MAAs, MATs, and LCM, ensuring compliance with regulatory guidelines.
- Identify regulatory scientific data needs and resolve regulatory issues.
- Serve as the primary Health Authority contact for routine communications related to submissions.
- Assist in preparing for and participating in regulatory authority meetings, inspections, and response to agency questions.
- Collaborate cross-functionally to ensure regulatory compliance and support strategic initiatives.
- Bachelor's degree in a scientific discipline and a minimum of 5 years of regulatory experience; or Master's degree with a minimum of 3 years of experience.
- Solid knowledge and understanding of the drug development process and regulatory requirements for EU, US, and ROW.
- Experience in the preparation and submission of documentation to support regulatory submissions.
- Excellent oral and written communication skills.
- Strong technical and analytical skills to independently identify and solve problems.
- Proven ability to manage multiple projects, identify and resolve regulatory issues.
- Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting.
- Experience working cross-functionally on broad and strategic initiatives.
- Ability to work under pressure, meet time-sensitive deadlines, while maintaining a high level of quality.
- Fluent in English, written and spoken
Create a job alert and receive personalised job recommendations straight to your inbox.
#J-18808-Ljbffr-
Regulatory Strategist
4 weeks ago
United Kingdom Parexel Full timeRegulatory Affairs Strategist - UK/EU locations Parexel is seeking a Regulatory AffairsStrategist (Regulatory Affairs Consultant) with extensive experience in EU, US, and ROW markets. As a Regulatory Strategist, you will play a crucial role in providing regulatory representation in cross-functional teams, developing regulatory strategies, and advising on...
-
Senior Regulatory Affairs Consultant
4 weeks ago
United Kingdom Parexel Full timeSenior Regulatory Affairs Consultant (Label Strategist) We are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to: Conduct international labeling operations activities to...
-
Regulatory Affairs Strategist
3 weeks ago
United Kingdom Parexel International Full timeParexel is seeking a Regulatory Affairs Strategist (Regulatory Affairs Consultant) with extensive experience in EU, US, and ROW markets. As a Regulatory Strategist, you will play a crucial role in providing regulatory representation in cross-functional teams, developing regulatory strategies, and advising on regulatory expectations, requirements, and...
-
Regulatory Affairs Specialist
3 weeks ago
United Kingdom Meet Recruitment Limited Full time3 weeks ago Be among the first 25 applicants Senior Consultant Specialising In Regulatory Affairs I am working with a growing pharmaceutical company who provide over-the-counter (OTC) pharmaceutical products dedicated to enhancing the health and well-being of customers. They're currently in the next phase of growth for the company as they're...
-
Senior Regulatory Affairs Consultant
2 months ago
United Kingdom Parexel International Full timeWe are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental...
-
Senior Regulatory Affairs Consultant
2 weeks ago
United Kingdom Parexel International Full timeWe are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental...
-
Senior Regulatory Affairs Consultant
1 week ago
United Kingdom Parexel International Full timeWe are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental...
-
Senior Regulatory Affairs Consultant
1 week ago
United Kingdom Parexel International Full timeWe are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental...
-
Senior Regulatory Affairs Consultant
1 week ago
United Kingdom Parexel International Full timeWe are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental...
-
Senior Regulatory Affairs Specialist
4 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
2 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
1 week ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
1 week ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
1 week ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Regulatory Affairs Specialist
3 weeks ago
United Kingdom Meet Recruitment Limited Full timeRegulatory Affairs Specialist - Medical Device 3 weeks ago Be among the first 25 applicants Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance...
-
Regulatory Specialist
3 weeks ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...
-
Regulatory Specialist
1 month ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
-
Regulatory Specialist
1 month ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
-
Regulatory Specialist
1 month ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...
-
Regulatory Specialist
1 month ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...