Senior Regulatory Affairs Specialist II

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Manages and prepares complex submissions to various governmental regulatory agencies and assures assigned products are in compliance with domestic and international regulatory requirements with a specific focus on labeling and labeling requirements.

Primary Responsibilities:

• Act as Regulatory Affairs authority for specified key products/facilities/equipment with a main focus in labeling and labeling related activities.

• Manage and prepare complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements.

• Prepare and/or supervise recurrent and routinely requested data, listing, and notifications for assigned projects for submission to regulatory agencies with other departments and research of internal documentation, complete applications and forms, compose cover letters and summaries, assemble/format submissions in such a manner to facilitate the review process.

• Collaborate with cross-functional subject matter experts to identify documentation to support responses to regulatory agency inquiries.

• Act as a technical advisor on regulatory requirements for assigned projects and task forces for specific products (e.g. labeling specific projects).

• Initiates action to ensure appropriate internal policies and procedures are developed to comply with new or modified regulations.

• 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.

• Evaluate impact of new regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary.

• Mentor and support the professional development of staff.

• Perform other duties as required.

Knowledge, Skills, and Abilities:

• Ability to prioritize and manage multiple and possibly conflicting priorities.

• Ability to work independently to create labeling components for submission purposes while ensure technical information is accurate.

• Close attention to detail is required for reviewing consistency in terminology and look of labeling.

• Ability to work independently and initiate and manage contacts essential to ensure submission preparation.

• Ability to work as part of the regulatory team to meet group objectives and to lead and motivate.

• Ability to work with management of other Grifols departments in order to achieve the common business as well as regulatory objectives.

• Ability to review a document 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 summarize and effectively present complex information verbally and in writing to internal and external audiences, including regulatory authorities.

• 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 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.

Requirements:

• Bachelor's degree in relevant discipline, or equivalent work experience.

• Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience.

• Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required.

• Excellent written and verbal communication skills.

• Knowledge of applicable laws and regulations

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

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. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel 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. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws

Learn more about Grifols (~~~)

Req ID: 514654

Type: Regular Full-Time

Job Category: Regulatory Affairs