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Job title |
Associate Director, Regulatory Operations |
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Reports to |
Senior Director, Regulatory Affairs, CMC |
Job purpose
The Associate Director, Regulatory Operations is responsible for leading, managing and coordinating the submission and publishing activities for all regulatory filings to IND, BLA, DMF, etc. This position will work closely with the regulatory and publishing teams to ensure documents are compliant and submission ready. The ideal candidate will have in-depth knowledge of submission requirements for North American and European markets to ensure submission quality and compliance with health authority expectations.
Duties and responsibilities
- Manage preparation and organization (including content plans) for major and minor regulatory submissions to applicable regulatory agencies.
- For major submissions (full dossier, major amendment, and milestone meetings), coordinate with Regulatory Project Management for document generation; for minor submissions coordinate directly with Regulatory Liaison.
- Interface with third party publishing agencies for submissions both inside and outside the US to establish timelines and file submissions via electronic gateway.
- Develop and manage the regulatory submission calendar, and report on key submission milestones to internal stakeholders.
- Serve as point of contact for eCTD authoring templates and PDF specifications.
- Contribute to the development and maintenance of Regulatory Operations working practices and standard operating procedures.
- Identify resources and provide guidance for process updates due to changing regulations that impact submission strategies and technologies (i.e., SEND, CDISC, validation, etc). This includes but is not limited to identifying the validation checks needed to ensure compliance with eCTD specifications for applicable regulatory agencies.
- Serve as a resource for questions about regulatory submission requirements for applicable regulatory agencies.
- Provides expertise in translating regulatory submission requirements into practical, workable plans.
EDUCATION AND EXPERIENCE REQUIRED
This position operates in an office setting and may include 20% of travel.
Physical requirements
This is a largely sedentary role.
Direct reports
Could include: Regulatory Manager
- Experience in leading and managing submission activities for multiple major filings (IND, BLA, NDA)
- Bachelor’s degree and 5 years related experience
- Solid knowledge of submission requirements for North American and European health authorities
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Proven ability to be flexible amidst constantly shifting priorities and timelines
- Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving regulatory operations objectives
- Ability to interpret regulations and gain consensus in an environment where there may be more than one way of achieving a successful outcome
- Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status
- Excellent organizational skills, attention to detail and commitment to deliver high quality output under pressure
- Proficiency in Microsoft office suite (Word, Excel, Project) and Adobe Acrobat
- Experience working in an EDMS such as Veeva RIM
This position operates in an office setting and may include 20% of travel.
Physical requirements
This is a largely sedentary role.
Direct reports
Could include: Regulatory Manager