Supports both their individual departmental goals regarding the number of ANDAs to be filed and approved yearly by planning, managing, compiling, and assuring the quality of Abbreviated New Drug Applications (ANDAs) that are filed on time and responding to subsequent deficiencies completely and on time. Mentors and provides regulatory support to other analysts within the group.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Prepares, reviews, and submits Annual Reports to the FDA in eCTD format. Works with other departments and teams to obtain the appropriate documents. Uses knowledge of current guidance documents to review, assess, and approve all regulatory documents. (20% of time)
Writes, analyzes, and submits Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDAs)to the FDA in eCTD format. Educates other departments on documents needed for submissions. Demonstrates the ability to provide regulatory assessment and recommend strategy to other departments with minimal supervision.
Reviews regulatory and related publications to assure compliance and anticipates future regulatory action. Interprets and advises colleagues on up to date regulatory guidances and Code of Federal Regulations.
Manages multiple projects both development and lifecycle with minimal supervision. Coordinate and prepare responses to FDA deficiency letters and other agency requests. Critically review submission documentation and provide input to respective departments for necessary revisions. Educate other departments on requirements/documents needed. Evaluate/review changes to regulatory documents and provide recommendation for filing strategy.
Attends educational courses and seminars and brings knowledge back to the group. Evaluates processes and works towards improvements to gain efficiencies and Right First Time objectives by influencing peers with their leadership skills.
Provides mentoring and regulatory support to Analysts I and II in order to help drive the business and increase their exposure.
All other duties as assigned.
Six years of pharmaceutical experience preferably in a regulatory environment (real world practical knowledge in the pharmaceutical industry).
Knowledge of documentation to support regulatory activity.
Familiarity and applied understanding of USP, Pharmocopeia, Compendia, Code of Federal Regulations, ICH guidelines, and FDA Guidance for Industry.
Strong computer skills such as Microsoft applications (Outlook, Excel, Word, Access,Powerpoint), eCTD software skills preferred (Beyond Compare, Filezilla, Trackwise, Prism, Adobe Acrobat Professional.
Must possess good written and oral communication skills; knowledge of structure and content of the English language (the meaning and spelling of words, rules of composition, and grammar), the ability to read and understand information and ideas presented in writing and through spoken words and sentences, the ability to enter, transcribe, record, store, or maintain information in written or electronic form.
Ability to share knowledge, communicate according to your audience, and relay information for understanding. Ability to mentor peers.
Must possess demonstrated presentation, facilitation, and negotiation skills.
Ability to interact effectively across all levels of the organization.
Demonstrated project management skills. Ability to multi-task, plan, organize, and execute time lines with minimal supervision.
Demonstrated analytical skills- ability to analyze data, interpret trends, recognize issues or potential barriers, and use critical thinking/reasoning to determine appropriate response/recommendation.
Demonstrated teamwork skills- providing information and assistance to supervisors and co-workers in a collaborative manner which encourages trust, mutual respect, and shared purpose among team members.
Right first time- Ability to be exact or highly accurate with attention to detail in performing duties.
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Clinical Research/Medical Affairs/Drug Regulatory Affairs
As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...