The Regulatory Affairs Manager is responsible for preparing regulatory submissions, including INDs, ANDAs and NDAs for products, and for providing counsel on submission strategies for internal and external clients/customers.
Prepares regulatory submissions
Assist in the development of regulatory strategies and compliance
Provide regulatory counsel for drug development programs internally and externally
Maintain liaison with external clients, internal personnel and external consultants
Manage activities and budgets to achieve program objectives
Act as the responsible person for continuing to lead the company toward fully electronic submissions.
Act as the primary liaison with Informatics for identifying and procuring the appropriate hard and soft ware(s) to keep the company updated with the eCTD requirements.
Act as the responsible person to maintain/update a training curriculum on the eCTD submission.
Act as the responsible person to select vendor(s) to support eCTD readiness, implementation activities, and training process.
Act as the primary person to interact with counterparts in CROs or development partners on the eCTD or any submission issue.
Act as the primary liaison with the FDA to receive expert advice on the electronic submission.
Oversee the Regulatory Submissions Group and ensure timely coordination and publishing of various regulatory submission documents.
Excellent written and oral communication skills
In depth understanding of CoreDossier/Insight or comparable software system
Excellent organizational skills
Strong project management skills
Thorough understanding of new drug regulations
Effective facilitator and negotiator
Must be able to create and manage eCTD submissions using CoreDossier
Must be able to communicate effectively in a verbal and written form
Must be able to work proficiently with computers and general office equipment
Bachelors degree in science/health field (Pharmacy, Chemistry, Microbiology, or Biology);
Minimum 3 years of experience in regulatory submissions;
Minimum 2 years experience in the area of electronic submissions in the pharmaceutical industry or equivalent;
Knowledge and experience with CoreDossier is essential;
Expert knowledge of the ICH and FDA eCTD specifications;
Working knowledge of EU eCTD specifications a plus;
At least one year of experience in leading a successful electronic submission of IND, or marketing application;
Superb experience with the preparation of INDs, NDAs.
Please send resume and salary requirements to HR@horizonph.com. No phone calls please.
Horizon Pharmaceuticals, Inc. is an Equal Opportunity Employer dedicated to providing equal opportunity to all employees and applicants regardless of race, color, age, gender, sexual orientation, national origin, marital or veteran status, disability or any other basis protected by federal, state or local law. The company is committed to providing equal employment opportunity with respect to recruitment, selection and all terms and conditions of employment.