Summary: This position will be responsible for knowing all the applicable Biomanufacturing regulations and ensuring that they are followed. This position will coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials in support of client submissions to regulatory agencies.
- Responsible for supporting the partnership with clients in their submission process.
- Help to build and manage Chemistry, Manufacturing and Controls (CMC) submission content, provide support on structure and content placement within electronic Common Technical Document submissions.
- Serve as point person working within regulations to expedite the lifecycle maintenance of products using a strong understanding of internal procedures, guidance and regulatory precedence.
- Triage and support communications between our clients, FDBT contributors and specialists.
- Support efforts around CMC submission by providing knowledge of ICH eCTD and evolving global agency standards.
- Implement and in some cases help interpret global regulations and guidance’s and look into regulatory precedence into submission processes and publishing standards to ensure final document content accuracy to content and structure alignment with local regulatory requirements.
- Support a collaborative environment within the FDBT regulatory group that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge CMC development support team to reach the best solutions.
- Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and sites.
- Facilitate document retrieval during regulatory inspections
- Provide strong guidance in the personal development of direct reports
- Perform other duties as assigned.
Required Skills & Abilities:
- Self-motivated with a drive for excellence
- Positive attitude and strong interpersonal skills
- Honesty, integrity, respect and courtesy with all colleagues
- Creative and can work with minimal supervision following internal procedures balanced with independent thinking
- Resilient through operational and organizational change
- Exceptional planning and organizational skills and the ability to multi-task and meet deadlines is required
- Requires the ability to communicate effectively using speech, vision, hearing and written word
- Must be able to walk or move or drive between locations
- Interacts with all departmental staff, including giving training and / or presentations to small and large groups
- Apply knowledge of cGMPs on a daily basis, as applicable
- Adhere to the standards of quality ruled by current GMP and the company Quality Policies and site SOPs
- Ability to accurately complete required documentation
- Excellent organization, detail oriented and accurate
- Knowledge of MS Office (Word, Excel, Outlook)
Preferred Experience, Behavioral Competencies, Skills & Abilities:
- Knowledge of pharmaceutical drug development or industry related experience preferred.
- Knowledge of Agency submission procedures and practices. Knowledge/awareness of emerging electronic submission standards.
- Ability to operate and manage operational requirements and lead direct report(s) in a regulated environment.
- Excellent technical writing and presentation skills. Author and/or update standard operating procedures, work instructions, or policies.
- Negotiation and influence skills, attention to detail and ability to effectively prioritize
- Proven effective teamwork skills: able to adapt to diverse interpersonal styles.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must be experienced in Microsoft Office suite of applications, especially Word, Excel and PowerPoint.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Must be willing to work flexible hours
- Experience prolonged standing, some bending, stooping, and stretching
- Ability to sit for long periods to work on a computer
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
- Attendance is mandatory
BA/BS in life sciences, information technology, or relevant field with 10+ years of relevant experience in an FDA regulated environment