Director / Senior Director RA Operations
Proclinical is currently recruiting for a Director/Senior Director of RA Operations with a global pharmaceutical company located in Gaithersburg, MD. Successful candidate will work in close collaboration to support and assist the Head of Regulatory Affairs to implement and coordinate all aspects of regulatory activities as needed to support the continued development and approval of the companies investigational vaccines.
- Manage and oversee development of Regulatory operational strategies.
- Manage Regulatory Operations staff and submissions group; coordinate workload for various programs including external vendors/consultants; and grow department according to corporate needs for eBLA submission.
- Business system owner for Regulatory publishing/submission solutions (assess and implement solutions).
- Responsible for formatting, publishing, and submitting Regulatory documents in CTD/eCTD format; and managing life-cycled submissions, such as BLAs, INDs, and NDAs in the US, and MAAs and CTAs in Europe -- includes organizing the submission security, review process, preparing sections, reviewing for completeness and appropriateness, and formatting for submission.
- Coordinate submissions in a team-setting in time-intensive situations.
- Develop/maintain style guides, templates, and Standard Operating Procedures related to Regulatory Operations activities.
- Provide intra- and inter-departmental training on preparing submission-ready documents, electronic publishing and submissions.
- Business system owner for EDMS R&D Repository.
- Representative for governance committees associated with Regulatory Affairs-related electronic solutions.
- Establish appropriate Regulatory metrics for global submissions.
- Maintain core company data sheets, package inserts, and country-specific labelling.
Skills and Requirements:
- BS/MS in a related science field.
- A minimum of 10 years in the in Regulatory Affairs Operations, a minimum of 7 years in a Regulatory Submissions-based position, and a minimum of 5 years managing others.
- Minimum of 3 years leadership experience is required.
- Comprehensive knowledge of drug development process, drug laws, regulations and guidelines.
- Previous experience developing eCTD-compliant submissions using validated content management systems.
- Hands-on working knowledge including technical/electronic background, experience in regulatory submissions and publishing activities, and secure product lifecycle management.
- Proficient in major regulatory e-submission software (e.g., Adobe Acrobat, US FDA ESG), as well as Microsoft Office Suite (e.g., Word, Excel, PowerPoint).
- Familiarity with CTD, ICH, GCP, and other standards.
- Ability to work independently and within a group setting and to interact effectively with different functional departments.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
- Ability to establish and build collaborative relationships with staff, colleagues, and regulatory authorities to support developmental programs.
- Possesses strong critical and logical thinking.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.