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Senior Director, Global Regulatory Affairs

Overview

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.

Responsibilities

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

  • The ability to support periodic business travel (i.e. Local/international site visits, external conferences) as necessary (~10%)

Qualifications

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

What Repligen Offers

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.

What You Should Know About Senior Director, Global Regulatory Affairs, Repligen

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.

Frequently Asked Questions (FAQs) for Senior Director, Global Regulatory Affairs Role at Repligen
What are the key responsibilities of the Senior Director, Global Regulatory Affairs at Repligen?

The Senior Director, Global Regulatory Affairs at Repligen is responsible for the oversight of regulatory compliance for all products. Key responsibilities include leading and developing a regulatory subject matter expert team, maintaining regulatory documentation, supporting product development, managing audit programs, and effectively communicating compliance risks to senior management. This role is fundamental to ensuring that Repligen meets all international regulatory standards and enhances product availability.

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What qualifications are required for the Senior Director, Global Regulatory Affairs position at Repligen?

Candidates for the Senior Director, Global Regulatory Affairs at Repligen should possess a BS in an engineering discipline, along with a minimum of 15 years of regulatory compliance experience and at least 8 years in a leadership role. Comprehensive knowledge of hardware and consumable product regulations, coupled with effective communication skills across global stakeholders, is essential. Experience within the life science or biopharma industry is highly desirable.

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How does the Senior Director, Global Regulatory Affairs role at Repligen support product development?

In the Senior Director, Global Regulatory Affairs role at Repligen, you will provide critical regulatory compliance guidance during the new product development process and for any product changes. This ensures that all new developments align with regulatory requirements, minimizing potential delays in product availability and compliance.

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What does the regulatory compliance monitoring program involve for the Senior Director, Global Regulatory Affairs at Repligen?

The regulatory compliance monitoring program led by the Senior Director, Global Regulatory Affairs at Repligen involves continuous oversight of international standards, leveraging both team members and third-party support when necessary. This proactive approach ensures that Repligen products remain compliant and up-to-date with evolving regulations.

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Is travel required for the Senior Director, Global Regulatory Affairs position at Repligen?

Yes, the Senior Director, Global Regulatory Affairs role at Repligen may require periodic business travel, both locally and internationally. This typically encompasses about 10% of the role, facilitating site visits and participation in external conferences, thereby enhancing networking and collaboration opportunities in the field.

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Common Interview Questions for Senior Director, Global Regulatory Affairs
Can you describe your experience in leading a regulatory team?

In answering this question, focus on your leadership style and how you've successfully developed your team's competencies. Discuss specific examples of mentoring and training, as well as how you've fostered a collaborative environment that encourages continuous improvement.

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How do you stay updated with the evolving regulatory landscape?

It's important to convey your commitment to staying informed through regular review of regulatory publications, attending seminars, and engaging with industry groups. Explain how this knowledge informs your decision-making and strategies in your role.

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What process do you follow for ensuring compliance during product development?

Outline a systematic approach that you take during product development, including input on regulatory requirements from the outset, regular compliance checks, and inter-departmental collaborations. Highlight how this proactive strategy prevents compliance issues later in the development process.

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How would you handle a compliance audit with a significant finding?

Discuss the steps you would take to address significant findings during an audit, emphasizing immediate corrective action and subsequent preventative measures to avoid recurrence. Illustrate your ability to maintain transparency and communicate effectively with stakeholders throughout the process.

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What methodologies do you use for risk assessment in regulatory compliance?

Describe a structured risk assessment process that incorporates both qualitative and quantitative measures. Share how you engage your team in identifying risks and the steps you take to establish mitigation plans, demonstrating a comprehensive understanding of regulatory requirements.

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How do you approach developing regulatory SOPs?

Convey your method for developing regulatory Standard Operating Procedures (SOPs), including gathering input from various stakeholders, ensuring alignment with global regulations, and integrating continuous improvement principles. Discuss how clear documentation supports efficiency and compliance.

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Can you give an example of effective cross-functional collaboration you've led?

Provide a specific example of a successful project where you collaborated across departments. Discuss how you facilitated communication, navigated diverse priorities, and achieved alignment on regulatory objectives, showcasing your interpersonal and leadership skills.

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What challenges have you faced in regulatory compliance and how did you overcome them?

Select a challenge you've encountered, explain the context, and discuss the steps you took to resolve the issue. Emphasize problem-solving techniques and any long-term improvements that resulted from your experience.

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How would you assess the regulatory risks of a new product?

Discuss a pragmatic approach to assessing regulatory risks, including identifying relevant standards, conducting gap analyses, and engaging with regulatory bodies as needed. Stress the importance of early identification of risks to facilitate smooth product launches.

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What role does training play in your regulatory compliance strategy?

Emphasize the critical role of training in ensuring compliance. Describe your strategies for developing training programs for the team and other departments, ensuring everyone understands regulatory requirements and their part in maintaining compliance.

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TEAM SIZE
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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 14, 2025

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