|
ESSENTIAL FUNCTIONS:
1. Lead product development teams with regard to regulatory issues and requirements. Responsible for the assembly of NDAs/ANDAs and other regulatory filings for drugs: collecting relevant information from other departments, writing the application, directing Assistants/Coordinators on assembling components of the application, and reviewing complete application for accuracy and completeness following regulatory authority guidelines. Submit to manager and/or director for review, revise accordingly, and ensure timely submission.
2. Develop regulatory strategies for projects. Defend regulatory position both internally and externally. Act as a point of contact on regulatory applications for assigned products - under minimal supervision, resolve issues/inquires/deficiency letters with regulators and follow-up to ensure initial applications are approvable. Manage submissions to meet timelines. Negotiate agreement to novel approaches to problem solving.
3. Anticipate regulatory consequences - develop and maintain knowledge of the history, manufacture, and materials of assigned products and product lines in order to assess (1) the consequences of regulatory changes for the product and (2) the regulatory consequences of changes in the manufacture, materials, or marketing of the product.
4. Maintain high level of knowledge of regulations, the regulatory process, and the application of regulations to assigned products and projects - expand regulatory background through work on projects, seeking guidance or advice from others when necessary, and attending relevant training.
5. Facilitate among other Mallinckrodt employees an understanding of the regulatory drivers and risks as well as the regulations themselves. Help other departments incorporate regulatory requirements early in the product planning process to speed the assembly and approval of applications.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1. Must be able to implement regulatory strategies based on current regulations and guidances to take a project from early development through market approval to product retirement.
2. Should handle routine details and unexpected changes without losing focus on own projects.
3. Determine task priorities and delegate responsibilities to assistant/coordinator staff as appropriate..
4. Ability to persuade others to do things out of the ordinary.
5. Willing to work extended hours until tasks complete.
MINIMUM REQUIREMENTS:
Education required/ preferred:
Minimum educational experience requires a B.S. (B.A.) in chemistry, pharmacy or other life science or equivalent years experience.
Experience:
1. Succesful candidate will
have a minimum of 3-5 years experience in a pharmaceutical regulatory affairs
environment with at least 4 years in regulatory affairs.
2. Previous successful FDA submission experience required.
3. European Marketing Authorization experience helpful.
Preferred Skills/Qualifications:
1. Knowledge of Windows
based software programs such as Word, Excel and Access.
2. Background in manufacturing, marketing, quality assurance sufficient to understand
how products are produced and marketed.
3. Understands regulatory application processes and the basis of regulations.
4. Background in the chemical and life sciences sufficient to interpret data/information,
review the work of others for technical adequacy, draft an application, and
interact with reviewers at the Agency.
5. Familiarity with Pharmaceutical manufacturng equipment and technology is
of value for this position.
Skills/Competencies:
1. Fundamental knowledge
of federal acts and regulations affecting proposed and marketed products.
2. Excellent oral and written communication skills.
3. Ability to work well with various departments and people.
4. Capable of making consistent, sound regulatory decisions.
5. Must be able to work with minimal supervision.
6. Must work well under tight deadlines.
7. Candidate must be very detailed oriented and be proficient at reviewing and
editing documentation.
Other Skills:
Allocates own time efficiently. Handle multiple demands and competing priorities. Willing to take the initiative to learn new tasks/take on more responsibility.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Position reports to Manager of Regulatory Affairs.
Assisted in job duties by Regulatory Assistants, Coordinators and Administrative Personell.
Will have frequent interaction
with manufacturing, quality, research and development, analytical tesing laboratory,
stability testing laboratory and marketing personell as well as various contacts
within FDA.