Manager/Sr. Manager, Regulatory Affairs (Labeling)

Summary:

Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors.

Primary Responsibilities:

• Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities.
• Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products.
• Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.
• Prepare responses to regulatory agency inquiries.
• Coordinate with local authorities and Quality standards and controls required for product registration testing.
• Represent the regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation (if required) to regulatory authorities. (e.g. labeling specific projects).
• Represent the regulatory function on project teams as related to worldwide product registrations. Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions.
• Collaborate with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from affiliates or third parties for meetings with regulatory authorities.
• Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling.
• Request and obtain all required FDA export documentation required for registration and routine product shipments.
• Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary.
• Maintain worldwide product registration status and distribute routine updates to commercial, sales and Quality to determine where registered products can be marketed.
• Perform other duties as required

Additional Responsibilities for Senior Manager:

• Leads a small group of products and personnel to facilitate global labeling changes and/or submissions as needed.
• Provide sound technical regulatory guidance to management on labeling related items.
• Provide sound technical regulatory guidance to management on proposed projects/changes with a solutions oriented focus regarding worldwide licensure and submission strategy.
• Train and continuously mentor staff to develop knowledge of submission preparation, worldwide regulations/guidelines for large and routine submissions.

Knowledge, Skills, and Abilities:

• Ability to prioritize and initiate contacts essential to labeling submission preparation.
• Ability to work independently and initiate contacts essential to create labeling components for submission preparation and ensure technical information is accurate.
• Knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling.
• Ability to clearly communicate verbally and in writing with internal and external contacts that may include industry representatives, affiliates, third parties and regulatory authorities in various countries.
• Ability to work with management of other Grifols departments to achieve common business goals as well as regulatory objectives.
• Ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.
• Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents
• Ability to work with other computer systems for filing supplements and reports.
• Ability to interpret and effectively communicate regulatory requirements internally as well as to distributors/affiliates with a specific focus in labeling.
• Ability to successfully interact with external contacts which may include worldwide distributors / Grifols affiliates / regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.
• Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

Preferred Background:

• Advanced degree with clinical experience
• Extensive knowledge and experience developing drug/biologics labeling for the US market
• Experience working on global labeling initiatives and submissions
• Familiarity with electronic labeling systems and regulatory publishing tools
• Demonstrated leadership in cross-functional team settings
• Excellent verbal and written communication skills

Minimum Requirements for Manager:

• Bachelor’s degree in relevant discipline, or equivalent work experience industry regulatory experience.
• 6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience.

Minimum Requirements for Senior Manager:

• Bachelor’s degree in a relevant discipline (such as science and technology is preferred) or equivalent education work experience
• Minimum of 8 years of directly related/industry experience. Of the experience, a minimum of 3 years of supervisory experience is required.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.