Overview

Job Summary

Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area. Responsible for managing and leading the work of direct and indirect reports, both individual contributors and people managers. Activities are performed in accordance with standard operating procedures (SOPs), Quality Management Systems regulations, Human Resources, Environment, Health and Safety, and other company policies. As a member of the Werfen management team is responsible for role modeling Werfen Values and Role of the Manager competencies and expectations.

Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for the following, under the direction of Department Leadership. Responsible for managing a team of technical staff to develop regulatory plans for products, to prepare regulatory submissions such as 510(k), EU IVDR Technical Documentation, etc, to manage communications with Regulatory Agencies e.g. FDA, EU Notified Bodies, Health Canada, etc., For on-market products, the Regulatory Affairs Manager will oversee and assist in conducting regulatory market authorization impact assessments for product changes and associated regulatory submissions in the regions where products are marketed. The Regulatory Affairs Manager will oversee, and assist in the review of promotional materials to comply with regional regulatory requirements concerning advertising and promotion. The Regulatory Affairs Manager will champion continuous improvement efforts and lead department initiatives. This role will also be responsible for managing the regulatory intelligence program in collaboration with internal and external stakeholders and supporting initiatives for global regulatory compliance for Werfen invitro diagnostic (IVD) products.

Responsibilities

Key Accountabilities

• Teamwork: Coordinate with department leadership and other cross-functional areas including R&D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, product changes, international product registrations, review of Advertising & Promotional Materials, etc. Model effective team collaboration behavior.
• New Product Development Support: In collaboration with Department Leadership, assist the Regulatory Affairs team in developing regulatory plans and oversee implementation for introducing new products in various geographies, including but not limited to the United States, European Union, Canada, Australia, Japan, China, etc. Partner with regional partners globally as needed to ensure product development plans are comprehensive in addressing global regulatory requirements and supporting global regulatory approvals. Oversee and assist the Regulatory Affairs team in preparing and submitting regulatory submissions, including 510(k)s, Pre-submissions, IVDR Technical Documentation, etc. for new product development projects. Oversee and manage communications with Regulatory Agencies during product development and during the review of regulatory submissions. Ensure product development plans, analytical and clinical studies are aligned with Regulatory Agency expectations necessary for obtaining regulatory market approvals. Partner with Regulatory Affairs staff and cross-functional management to manage expectations and ensure overall smooth execution of regulatory strategies and plans in new product development projects. Ensure timely preparation of regulatory submissions through effective coordination of activities across Regulatory Affairs staff and cross-functional teams. Ensure regulatory submissions and associated communications with Regulatory Agencies are appropriately maintained in the internal document repositories.
• On-Market Support (Sustaining): Provide leadership, guidance and assistance to the Regulatory Affairs team in the regulatory impact assessments of changes on existing Market Authorizations that include but are not limited to design changes, changes to product composition, manufacturing processes, and the labeling of products. Oversee and assist in completion of regulatory submissions necessary for product changes. Review and approve product labeling, scientific papers, customer and public communications, advertising, and promotional materials to ensure compliance with regulatory requirements concerning advertising and promotion.
• Regulatory Intelligence: In collaboration with Department Leadership, oversee and perform ongoing surveillance of new and revised regulatory requirements globally. Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in the marketed geographies. Participation in trade and professional organizations is strongly recommended. Monitor and analyze the development of new and emerging regulations, guidances, and recognized standards in marketed geographies. Coordinate plans for complying with new and emerging regulations, guidances, and standards to affected functions. Communicate new regulatory requirements and regulations and their impact on the business or portfolio to senior management.
• Department Management: Establish and monitor priorities and goals for the Regulatory Affairs team concerning new product development support and sustaining of on-market products. Educate and broaden the regulatory knowledge of the department, other functions. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Maintain procedures and work instructions related to Regulatory processes. Perform Regulatory related periodic document review and update documents as necessary. Support regulatory inspections and third-party audits. Provide back-up support for Regulatory Team.
• Team Management: Responsible for overall performance of department operations, personnel and budget. Leads department to achieve department and company goals. Responsible for hiring, development and performance of team. Ensure a culture of accountability, teamwork, collaboration, continuous improvement and compliance to company policies and procedures, legal requirements and the Quality Systems. Ensure effective performance management and development activities are completed, including onboarding, training, setting expectations, and providing meaningful feedback. Maintain regular and transparent communications through effective use of one-on-one meetings, team meetings and other forms of formal and informal communications. Proactively manage employee relations issues; use judgement in consulting with department leadership and Human Resources. May include managing people managers to ensure business acumen, commitment to Werfen Values, as well as Role of the Manager comptencies & expectations.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• R&D Teams
• Project Management
• Marketing
• Quality Engineering
• Manufacturing
• Global Werfen RA/QA Personnel and Regional Partners
• Product Testing
• Post-market compliance

Qualifications

Minimum Knowledge & Experience

Education:

• Bachelor’s degree in bioengineering/biomedical engineering,biochemistry, chemistry, molecular biology, or related technical science discipline required. Advanced degree preferred.
• Regulatory Affairs Certification preferred

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Experience:

• Minimum 8 years of experience in Regulatory Affairs, of which a minimum of 5 years must be in IVD Regulatory Affairs.
• Minimum 5 years of experience in managing regulatory professionals including responsibility for staffing management, professional development, budget management and adherence with procedures, policies and regulations.
• Demonstrated success in obtaining regulatory approvals in the major geographies including but not limited to the US, EU (under IVDR) and other major geographies.
• Hands-on experience in preparing regulatory submissions including 510(k) and IVDR Technical Documentation and managing relationships and communications with Regulatory Agencies such as FDA, EU Notified Body, etc.
• Experience managing relationships with a variety of stakeholders and cross-functional teams.
• Experience with scientific writing and communications

Skills & Capabilities

• Strong knowledge of regulatory requirements for obtaining Regulatory Approvals in the United States, EU (under IVDR), Canada, and Australia.
• Working knowledge of regulatory requirements for obtaining global Regulatory Approvals in Asia Pacific, Latin America and Middle East.
• Strong knowledge of IVD product development process.
• Strong knowledge of requirements, methods and data analysis utilized in the analytical and clinical validation of IVD products. Understanding of CLSI guidelines preferred.
• Strong ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.
• Strong skills in verbal and written communication including scientific writing and presentation.
• Strong ability to mentor, train, and develop skills of staff in regulatory knowledge and related processes. Ability to manage and coordinate the activities of direct reports.
• Strong skills in leadership, influence, and negotiation.
• Ability to lead cross-functional projects with a focus on collaboration and teamwork to a timely and effective conclusion.
• Ability to function effectively with ambiguity in a rapidly changing environment.
• Ability to develop proactive and creative approaches to problem solving.
• Advanced ability to organize and complete multiple tasks in a fast-paced environment.
• Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.
• Advanced knowledge of electronic publishing/file management system

Travel Requirements

Approximately <10% of time

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $90,000- $175,000 annual. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.