About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Provides regulatory affairs support by preparing labeling and supplements for FDA drug dossiers for new product presentations. May serve as a lead regulatory representative for some project teams.
Provides regulatory advice and support to assigned products/teams. Identifies and communicates regulatory needs and strategies. Maintains awareness of applicable regulations.
Prepares pharmaceutical submission supplements that meet FDA regulatory requirements and guidelines. Represents Regulatory Affairs at meetings and presents agreed upon regulatory positions.
PROBLEM SOLVING: Reviews critical documents and determines applicability and acceptability for regulatory submission, seeking guidance when necessary . Understands the content of the submission information and is able to ensure consistency within and between dossiers as appropriate. Able to follow scientific arguments and ensure data is complete and sound. Works independently with other functional areas to obtain all information required for change requests and submissions. Interprets regulations and assure regulatory compliance. • Exercises good judgment within policy and regulations. Must be able to easily deal with complexity and large bodies of work.
ACCOUNTABILITY: • Responsible for tracking and completion of assigned activities for a broad portfolio of molecules and platforms. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues. • Presents scientific data effectively orally and in writing in a logical and persuasive manner.
AUTHORITY TO ACT: • Independently prepares regulatory documentation for submission to FDA. Acts independently on all routine issues, makes judgments and executes.
A Bachelors degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject is required. A Masters degree is preferred. A Ph.D. is highly preferred.
Three to five years of experience in regulatory affairs, research, development or related area with experience working with RA.
Must have critical thinking skills, excellent writing skills, strong scientific skills, good interpersonal communication skills. Must be able to adroitly adapt to constantly changing expectations and want to and be able to learn very quickly, then apply those learnings to project programs.
Other Information - Internal
Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
Legacy Hospira grade 16
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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