Regulatory Affairs Manager – Combination Product

03 Mar, 2021

Jobs

Regulatory Affairs Manager – Combination Product

Vero Biotech LLC
Atlanta, GA
Description

Reporting to the Director of Regulatory Affairs, the RA Manager is responsible for representing the Regulatory department on sustaining and new product development teams and assisting in the support and execution of the regulatory and compliance strategy for VERO Biotech.  The RA Manager shall assess regulatory intelligence to assist in the development of regional and global regulatory strategies, as well as evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g. concept, development, manufacturing, marketing) to ensure product compliance. The RA manager will support day to day regulatory operations including providing regulatory advice and support to assigned project teams, assessing lifecycle changes (drug and device design control), preparing regulatory submissions, and reviewing critical documents to determine applicability and acceptability for regulatory submission. In addition, the RA Manager will assist the organization in ensuring regulatory compliance to established standards/guidance and implementing procedures to ensure that the business unit’s regulatory program is effective and efficient. The RA Manager will look ahead at the changing regulations and proactively ensure the organization’s compliance to established standards and regulations. The RA Manager will provide guidance and work jointly with the project teams and key stakeholders to ensure compliance and regulatory goals are met while also achieving excellence. This position will work closely with other functional areas, such as Quality, Engineering, Operations, and Marketing to assure alignment to commercial regulatory requirements of company products.

Essential Duties and Responsibilities

• Prepares regulatory submissions (supplements, amendments, annual reports, etc.) for FDA drug dossier for new product presentations and/or lifecycle changes

• Develops regulatory strategies for approval in the US for new products in development

• Determines and communicates submission and approval requirements to core functional product teams

• Participates in the negotiation and interactions with FDA during development and review process to ensure submission approval

• Provides regulatory guidance for proposed product claims/labeling/packaging

• Ensures product safety issues and product associated events are reported to FDA

• Assesses the status of lifecycle changes to product, product labeling, processes, materials, etc. that is subject to an active application. Works independently with other functional areas to obtain all information required for change requests and submissions. Determines regulatory requirements and notification for such changes

• Interprets regulations and implements Regulatory Affairs policies and SOP’s to ensure organization’s regulatory compliance

• Identifies and communicates regulatory needs and strategies, considering both drug and device regulations

• Supports UDI and GUDID Database operations

• Reviews critical documents and determines applicability and acceptability for regulatory submission, seeking guidance when necessary

• Understands the content of the submission information and ensures consistency within dossiers. Able to follow scientific arguments and ensure data is complete and sound

• Exercises good judgment within policy and regulations

• Must be able to easily deal with complexity, uncertainty, and large bodies of work

• Interfaces with other team leaders to ensure coordination and implementation of consistent standards and processes

• Proofreads documents and support Regulatory Operations to review and publish final regulatory OPDP submissions

• Supports leadership by providing regulatory guidance in adverse reaction and product malfunction/injury/death decisions

• Assesses proposed regulations and communicate new requirements and their probable effects.

• Other duties as assigned by Regulatory Affairs leadership

The above is intended to describe the general content of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements.  Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

• Bachelor’s degree in Engineering, Science, or equivalent is required; Engineering is preferred

• A minimum of 5 years of Regulatory Affairs experience preferred; a minimum of 3 years required

• A minimum of 5-7 years of experience in an FDA regulated industry required (medical device and combination products, preferred)

• RAC certification or Advanced Degree (Masters) preferred

• Experience interacting with regulatory agencies preferred

• Excellent analytical and technical writing skills required (sample of technical writing shall be available upon request)

• Excellent interpersonal, written, and oral communication skills

• Must be able to interpret and apply government regulations

• Must be experienced in the translation of regulatory requirements into practical plans

• Must be a proactive contributor and work in close collaboration with others

• Strong organizational and planning skills, as well as strong attention to detail

• Accountable for results and goal attainment

• Experience using FDA Electronic Submission Gateway desired

• Ability to work independently with limited supervision, adapt to change and manage multiple tasks

• Technical knowledge of US regulations and ICH and GXP Guidelines

• Strong computer skills in Word, Access and Adobe Acrobat and working knowledge of electronic publishing/file management

• This position will require periodic travel (up to 10%) in the US

Learn more here

Job posted: 2021-03-03