Regulatory Affairs Director jobs in Middlesex, NJ

DIRECTOR REGULATORY AFFAIRS AND VALUE ADDED SERVICES

Our team in South Plainfield currently has an opening for a Director Regulatory Affairs and Value Added Services

YOUR ROLE & RESPONSIBILITIES

Job Summary:

To lead and manage the strategic and operational performance of the Quality, Regulatory and Documentation Life Science, BSP Americas team, ensuring successful delivery of the Life Science strategy, Key Performance Indicators (KPIs) and objectives.
To drive compliance culture with cGMP and other applicable regulatory requirements for BSP products, and champion this across the wider Brenntag group. Contribute to the development of Life Science systems and processes that improve quality assurance, product integrity and customer confidence.

To support the commercial team and contribute to the overall commercial success of the Life Science team.

To manage all aspects around project pipelines on Value Added Services.

Job Description:

• Build and establish the Regulatory department business strategy and plan. Set team objectives, key KPIs, prioritize, delegate, and monitor work to ensure the optimization of resources to deliver first-class service to customers both internally and externally.
• Hire, manage, motivate and coach direct reports to successfully fulfil their roles. Establish and maintain individual and department training plans to improve knowledge and skills and ensure business needs can be met as required.
• Oversee BSP product quality, regulatory and documentation requests for internal and external customers and act as a main point of contact for BSP suppliers and customers on escalated quality issues.
• Oversee BSP product and supplier approval processes and ongoing assessments, ensuring compliance with regulatory requirements in all applicable regions.
• Be the focal point for regulatory consulting experts, as required per country/ market.
• Prepare, review and approve technical and quality agreements for BSP customers, aligned with BES sites capabilities.
• Communicate and ensure awareness of customer requirements throughout the Life Science team and distribution site network.
• Oversee BSP product change notifications in line with BSP customer quality agreements and Brenntag policies and procedures.
• Support BSP customer and regulatory audits/inspections, as required.
• Carry out customer site visits to attend meetings as a quality representative of Brenntag and to support commercial opportunities.
• Support Brenntag distribution sites with implementation of certification schemes and registrations for distribution of BSP products.
• Compile and maintain a high level BSP Americas Life Science Overview FAQ and site specific information packs / SAQs on strategic cGMP Brenntag Americas sites.
• Collaborate with other areas of the business to ensure that systems and procedures to support quality and regulatory compliance are developed, implemented, maintained, and supported.
• Identify training needs and develop training resources for the wider Brenntag group in collaboration with relevant departments.
• Compile and maintain an up-to-date system with regulatory information that is available for each region. Establish links with relevant regulatory authorities to receive regulatory updates on new and proposed legislation that may impact the business. Assess and communicate details on changes to the Pharma Services team and distribution site network.
• Compile regular reports on department KPI performance, progress against objectives and other reports as required.
• Attend industry trade shows as a quality representative of Brenntag and to support commercial opportunities.
• Hold or work towards membership of an appropriate professional body or industry group.
• All other duties, as assigned.

YOUR PROFILE

Education and Experience:

• Degree in Microbiology, Biochemistry, Chemistry or suitable corresponding experience
• 10 years of professional experience in Quality, Regulatory and Documentation with demonstrated track record in solutions implementation with ability to lead and influence people through effective communication.

OUR OFFER

INTERESTED?

We look forward receiving your application.

Brenntag provides equal employment opportunities to qualified applicants and employees of all backgrounds and identities to create a workplace where difference is valued because it forms a resilient and more innovative organization. We do not discriminate on the basis of age, disability, gender identity, sexual orientation, ethnicity, race, religion or belief, parental and family status, or any other protected characteristic. We welcome applications from women, men and non-binary candidates of all ethnicities and socio-economic backgrounds.

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