CAREERS

ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Life cycle management and regulatory filing maintenance activities;
• Preparation, review and submission of FDA required Annual Reports for Abbreviated New Drug Applications for Mylan Institutional including scheduling and coordinating receipt of documentation/information, preparing cover letters describing changes made to the application, and tracking progress of their preparation. This also includes the review of documents, and utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements. Failure to prepare accurate and timely Annual Reports could result in FDA action which may include the removal of products from the marketplace. Assess and review documentation to ensure compliance with product licences.
• Preparation, review and submission of amendments and supplements to product marketing applications.
• Recommend the appropriate regulatory reporting mechanism using FDA regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation.
• Provide departmental management regulatory guidance and input to other departments (QA, QC, Manufacturing, etc.) for planned changes.
2. New Product Submission Activities;
   
• Preparation of registration submissions, in CTD format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
• Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
• Provide a critical detailed review of technical documentation including product labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications, etc. prior to FDA submission.
3. Actively participate in project teams, as required.
4. Research information pertaining to marketing applications for other departments through the navigation of ANDA submissions and regulatory documentation system.
5. Maintain current knowledge of FDA regulations and guidance?s pertaining to changes to approved regulatory applications by utilizing the FDA website and attendance at conferences.
6. Perform other duties as assigned.

QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE
Must possess;
a strong knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA Guidance's for Industry (particularly those dealing with sterile products).
Knowledge of the regulatory process pertaining to drug development, registration, review and approval.
Knowledge of parenteral product submissions.
Experience in writing and submitting regulatory documentation.
Knowledge of cGMP awareness and compliance.
Knowledge of sterile products and their unique regulatory requirements.

SKILLS AND ABILITIES
Excellent communication skills, both oral and written.
Experience in writing and submitting regulatory documentation.
Strong organizational skills.
Good interpersonal skills.
Accuracy and attention to detail.
Strong work ethic.
Ability to respond quickly to a changing regulatory environment.
Computer skills, E-mail (Lotus Notes) Microsoft Word, Excel, Powerpoint an advantage.

SUPERVISION
This position operates semi-autonomously and consults with departmental management on an as-needed basis.

EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) in a science related discipline and 2-4 years? regulatory experience in the pharmaceutical industry.
However, a combination of experience and/or education will be taken into consideration.


LICENSES/CERTIFICATIONS
Topra certification or RAC, preferred.

LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.

MATHEMATICAL SKILLS
Ability to read, understand and interpret mathematical technical data.

REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.