Primary Responsibilities:

• Creates and maintains Structured Product Labeling (SPL) submissions with the FDA.
• Performs all related drug listing activities with FDA and serves as ABC's contact for the drug listing branch.
• Acts as a core member on new product launch team to provide regulatory guidance and develop regulatory strategies and timelines.
• Prepares documents necessary for new product market approvals and continuance during product life cycle management.
• Interacts with applicable regulatory bodies.
• Participates in inspections/audits by FDA or other regulatory bodies by producing requested documents or answering any inquiries for information
• Interacts with other cross functional departments to ensure proper coordination of information to meet regulatory requirements.
• Acts independently to determine and coordinate methods and procedures on new assignments.
• Responsible for governmental reporting, as assigned.
• Performs related duties as assigned.

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 writing are 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 handle multiple ongoing projects/tasks is required.

• Excellent proofreading/editing skills; excellent usage of the English language (spelling, grammar and punctuation).
• Ability to positively interact with cross-functional colleagues.
• The ability to work well under pressure and adapt to changing priorities.
• Experience and knowledge of Structured Product Labeling (SPL).
• Knowledge of FDA regulations/guidelines regarding labeling requirements.
• Experience with electronic document management systems.

What Cencora offers

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 time

Equal Employment Opportunity

Cencora 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 888.692.2272 or email hrsc@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