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Regulatory non-clinical Director

Status: Active
CompanyRVAC Medicines
LocationBoston, MA
Expiration2023-06-14
How to Apply

Please send you resume to CareerDevelopment@rvacmed.com

Responsibilities:

1. Responsible for non-clinical regulatory deliverables and related activities for RVAC key registrations and product lifecycle management. Establishes and communicates regulatory strategy to meet the GRA priorities and objectives, as well as provides direction, data assessment and conclusions within and across functions. 

2. Works with RVAC cross-functional teams/3rd party, to assure alignment of registration strategy for all new or modified non-clinical dossier and high quality of developments. Ensures regulatory requirements of target submission markets are considered in the project plans and considers impact of including other regions or countries.

3. Provides non-clinical regulatory expert advice to the cross-functional teams regarding new opportunity evaluations (e.g., due diligence, manufacturing changes) and interpret non-clinical requirements, guidelines, procedures, and policies for RVAC product development, registration, and life-cycle management. Interacts with cross-functional teams to deliver high quality non clinical dossiers, documents, and materials in accordance with GRA priorities and agreed

timelines. (e.g., non-clinical sections of Briefing Books for Health Authorities (HAs) meetings, INDs/CTAs, BLAs/MAAs).

4. Provides non-clinical support to GRA in interactions with Regulatory Agencies/HAs and experts.Interacts directly with Regulatory Agencies/HAs via email, phone, or meetings, depending on project/affiliate needs.

5. Provides non-clinical evaluations for potential changes as requested and follows up to ensure regulatory compliance. Creates, maintains and continually evaluates/improves non-clinical Regulatory processes, working standards, and systems.

6. As non-clinical expert will be expected to contribute to the Global Regulatory Intelligence potentially covering Biology, Vaccine area, and new technologies, liaising within GRA, or externally as required.

7. Contribute to special assigned activities and projects within the team or represent GRA in cross functional assignments, projects.

 

Qualifications:

1. In this role you will require a bachelor’s degree (or equivalent and above) within a relevant subject such as basic medical science, animal medicine, or a related scientific discipline.

2. non-clinical regulatory affairs, discovery and early development experience gained with direct involvement in regulatory submission preparation across all stages of development.

3. 8 plus years’ experience of non-clinical development Regulatory Affairs in Pharma/veterinary drug company, with at least 5 years at a senior manager level.

4. Strong knowledge of worldwide non-clinical regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new vaccines in development

5. Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.

6. The ability to successfully influence and negotiate issues at a senior level within RVAC and/or with regulatory agencies in a variety of settings.

7. Strong verbal and written communication skills with good attention to detail.

8. Excellent team working abilities and effective influencing skills.

9. Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.

10. Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.

11. Experience of Agency interactions and/or submissions in US, EU, Australia, and China.

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