The Senior Director, Global Regulatory Affairs will report directly to the VP, Global Quality.
This role will be accountable for the Regulatory oversight of all Repligen products and will be responsible for leading and developing a team of regulatory subject matter experts. The Regulatory Affairs team will monitor external product compliance requirement and advise the business on any changes and actions to be taken. The Regulatory Affairs team will maintain regulatory documentation supporting Repligen Hardware and Consumable products in line with industry & customer requirements.
This senior leadership position will be required to participate in business reviews, external forums and support customer interactions, as necessary, including acting as spokesperson for Repligen Regulatory Compliance with governmental entities and global regulators. The ability to effectively communicate Regulatory Compliance, risk and mitigations to Senior Management across the organization, is essential.
The Senior Director Global Regulatory Affairs must have the ability to:
Lead & develop a team of Regulatory subject matter experts
Install a continuous Regulatory compliance monitoring program leveraging direct team member and 3rd party
support as necessary
Maintain a Regulatory compliance documentation database that supports Product Regulatory support files
Provide Regulatory compliance guidance during New product development and product changes
Manage a regulatory compliance audit program (i.e. NRTL audits for TUV, Intertek, and UL 508a)
Support customer regulatory enquires
Support product change control assessments
Support facility ISO certification audits, as required
Effectively problem solve and develop corrective action plans as needed
Maintains regulatory compliance through continuous monitoring of International regulatory standards (e.g. WHO, EMA, FDA, ISO)
Develops & maintains Global Regulatory SOPs that define the cross functional RACI, including regulatory training requirements for the applicable business functions
Ensures all regulatory activity is understood and planned to prevent delays in product availability and launch.
Supports regulatory testing requirement during product development and design modifications
Ensures review and approval of product labelling in line with global regulations
Maintains ETL and NRTL registrations and support quarterly compliance audits
Supports CE testing and global environmental regulatory compliance
Promotes a quality-oriented culture
Qualifications/Skills:
- BS in Engineering discipline
- Minimum 15 years’ work experience in Regulatory compliance
- Minimum 8 years leading a team
- Demonstrated experience of working with regulatory bodies
- Ability to communicate effectively with global stakeholders on regulatory requirements
- Ability to identify continuous improvement to maximize productivity involving global regulatory requirements
- Excellent cross-functional engagement and influencing skills
- Highly organized and detail oriented
- Effective prioritization skills
- People development experience, including conflict resolution
- Comprehensive knowledge of Hardware and consumable product regulatory requirements (i.e. E&L, CE, RoHS, REACH, Prop65, Conflict Materials, WEEE, Nitrosamines, UL/CSA & ETL Marking, PFAS
Desired Compliance experience:
· Life Science/Biopharma Industry experience
· Masters Engineering Degree
· Demonstrated external influencing of standards
· RAPS certification
Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.
If you're an experienced regulatory professional seeking a pivotal role, look no further than the Senior Director, Global Regulatory Affairs at Repligen in Waltham. In this position, you'll take the lead in overseeing the regulatory compliance of all Repligen products, shaping the future of the company and its contributions to healthcare. Reporting directly to the VP of Global Quality, your leadership skills will shine as you develop and guide a talented team of regulatory experts. You'll play a vital role in monitoring compliance with international regulations, working closely with governmental bodies, and actively participating in external forums. Your keen eye for detail will help maintain essential regulatory documentation and support the development of new products, ensuring they meet rigorous compliance standards. As you navigate the world of regulatory affairs, your communication skills will be crucial in conveying compliance risks to senior management and resolving complex issues. With approximately 10% travel for site visits and conferences, this role offers the chance to engage with a diverse range of stakeholders. At Repligen, you’ll also find a culture that promotes quality and continuous improvement, providing a solid foundation for your career while making a meaningful impact on patient health worldwide. Join us at Repligen and help shape the regulatory landscape of life science products while enjoying a competitive package, generous PTO, and a collaborative, stimulating work environment.
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