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.