Location: Columbus,OH, USA
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Job DetailsThe Regulatory Packaging Specialist will coordinate governmental reporting and is responsible for the preparation of regulatory submissions required to market new or modified finished dosage form pharmaceuticals in both domestic and international markets (if applicable), including all relevant maintenance activities.
Location:American Health Packaging–Columbus, OH
Primary Responsibilities:
Requirements:
A bachelor's degree is required. A minimum of four (4) years of regulatory experience in the pharmaceutical industry OR an advanced degree and a minimum of three (3) years of regulatory experience in pharmaceutical industry are required. Solid knowledge of US FDA regulations and review processes are required. Practical experience in a pharmaceutical Regulatory Environment and experience interacting with US FDA is preferred. Excellent written, verbal communication and presentation skills are required; including the ability to communicate clearly, succinctly and effectively over the phone and in writingare required. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required. Ability to work as a member of a team in a timeline-driven environment with limited supervision is required. Being detail-oriented, while having the ability to handlemultiple ongoing projects/tasks is required.
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.###.#### or email...@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies:Affiliated Companies: Amerisource Health Services, LLC