Ra Dr - Regulatory Affairs Director, NDA, Clin
MO
Type:
Full-Time
Category:
Regulatory Affairs
Job ID:
858
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Opportunity Description:
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(314) St Louis Area
Regulatory Affairs Director -New Drugs
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Description |
The position of Director of Regulatory Affairs, in the Regulatory Affairs Department, requires an individual with direct regulatory affairs experience and experience managing a group of regulatory professionals in the development of new drug development programs. This person will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of high quality dossiers meeting the requirements of Health Authorities and the needs of the company;
ESSENTIAL FUNCTIONS:
1. Maintains current high level knowledge of regulations, the regulatory process, and the application of regulations to assigned products - expands regulatory background through work on projects, researching available documents and attending relevant training. Anticipates how future developments in the regulations for relevant therapeutic areas may effect drug development process.
2. Liaison with regulatory agencies during the development process and for assertively and successfully prosecuting marketing applications to ensure their timely approval.
3. Oversees those activities that lead towards the submission of high quality clinical trial applications, which meet clinical development timelines.
4. Directs resources and assures that activities will lead to the provision of adequate and proactive regulatory guidance into the Core Development Teams for new product development to ensure that the resultant development package is consistent with ICH guidelines and global regulatory agency expectations for new products.
5. Interacts with key functions of the company including R&D, Clinical Development, Manufacturing, Quality Assurance and Marketing.
6. Responds to inquiries from various departments regarding regulatory strategy, post-approval changes, etc. in a timely manner. Insures proper research was conducted prior to communicating regulatory strategy.
7. Drafts, circulates, and maintains department work instructions of essential job functions. Insure compliance with procedures among staff.
8. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review.
9. Provides training in various RA areas, including but not limited to: documentation review, EZSubs utilization, SOPs, work instructions, submission procedures, timeline management, regulatory procedures, FDA application types, review process, etc. Develops training programs for new department members.
10. Performs due diligence on Regulatory information for external collaboration projects. Provides regulatory strategy and support to contact manufacturers and partner companies, as necessary. Provides templates for document authoring and directs timeline, as appropriate.
11. Assists plant site RA with regulatory issues. Serves as liaison to site RA and QA personnel for product life cycle management. Provides regulatory requirement support and direction as necessary. Provide assistance during FDA audits as necessary.
12. Manages those activities that lead towards the submission of high quality CMC applications, facilitating pharmaceutical and clinical development timelines.
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| Requirements |
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Minimum qualifications are a BS in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities on new drug development programs.
Experience
1. Successful candidates will have a minimum of 12 years experience in pharmaceutical regulatory affairs or 10 years experience with an advanced degree in the sciences.
2. Experience working in multiple therapeutic areas.
3. Must have experience filing INDs and NDAs.
4. Experience obtaining approvals for new drug products and new indicqtions for existing marketed products.
Preferred Skills/Qualifications
1. Ph.D. degree in science.
2. Thorough knowledge of the medical science for the therapeutic areas they have worked within.
3. Experience in Oncology and/or Pain Management and knowledge of the regulatory requirements in these therapeutic areas.
4. Knowledge of the requirements to obtain regulatory approval including a thorough understanding of the clinical efficacy and safety standards.
5. Experience generating and executing the regulatory strategy for their assigned development programs.
6. Familiarity with clinical development process (e.g., clinical protocols, issues with conducting clinical trials, etc.).
7. Knowledge of the regulations for devices.
8. Understands regulatory application process and the basis of regulations.
9. Background in the chemical and life sciences sufficient to interpret data/information, review the work of others for technical accuracy and adequacy, draft application, and interact with reviewers.
10. Background in manufacturing, marketing, quality assurance sufficient to understand how products are produced and marketed.
11. Familiarity with pharmaceutical manufacturing equipment and technology.
12. Ability to confront challenging situations decisively and in a way that protects and extends the interests of the company.
13. Makes quick and accurate decisions based on previous regulatory experience when faced with uncertainty.
14. Awareness of political and organizational influences on decisions and factors on project timing and resource allocation.
15. Experience managing a group of regulatory professionals.
16. Ability to keep staff involved and committed to job functions in a complex, priority driven environment of projects with conflicting schedules and priorities.
17. Ability to inspire team to work with urgency without sacrificing accuracy to deliver complete, top-notch applications for submission to regulatory authorities. Drive high standards for work quality within group.
Skills/Competencies
1. Fundamental knowledge of federal acts and regulations affecting proposed and marketed products.
2. Excellent oral and written communication skills.
3. Knowledge of Windows based software programs such as Word, Excel and Access.
4. Strong interpersonal skills, including ability to remain calm, professional, diplomatic and positive.
5. Capable of making consistent, sound regulatory decisions.
6. Must work well under tight and conflicting deadlines.
7. Must be detail oriented and be proficient at reviewing and editing documentation.
8. Allocates own time effectively.
9. Allocate resources effectively across multiple projects.
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