Senior Manager, Regulatory Affairs, Operations

We are seeking a Senior Manager, Regulatory Affairs, Operations to join our team. The ideal candidate is independent and self-directed contributor who will be responsible for supporting regulatory activities for submissions to Health Authorities around the world for Xenon’s programs. This role will manage regulatory submissions, publishing activities, and submission archiving. This individual will have a strong understanding of FDA/EMA regulations and experience with life cycle management of regulatory submissions such as INDs, international clinical trial applications (CTAs), or marketing applications in electronic Common Technical Document (eCTD) format. It is essential the individual has excellent written and effective verbal communication skills, proficiency in project management, and is flexible and adaptable to working in a fast-paced and complex environment.

This position reports to the Director, Regulatory Affairs, Operations and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

• Maintain processes for regulatory submission document formatting, working with external publishing vendors, and transmittal to regulatory agencies.
• Manage contractual relationships and workstreams with external publishing vendors for building submissions in the eCTD structure and filing the output via the Electronic Submissions Gateway (ESG).
• Serve as the unblinded regulatory person for the sign-off (Covering Letter/FDA form 1571) and manage the submission of expedited safety reports (i.e., SUSARs) to the FDA. In addition, performing periodic review of safety submission trackers for submission compliance with regulatory timeline requirements.
• Support regulatory program leads and project teams in creating timelines for activities related to the preparation and publishing of regulatory submissions.
• Maintain the Xenon regulatory submission calendar and other internal trackers, provide status updates, and ensuring that stakeholders have the most recent versions for their reference.
• Provide advice from an operation’s perspective across all projects on the acceptability of regulatory submission and publishing timelines in regard to coordination of internal and external resources and vendors.
• Contribute to internal process improvements that impact on Regulatory department operational functions.
• Communicate current and emerging publishing and routine reporting regulatory requirements to stakeholder groups within Xenon.
• Advise on and direct the evaluation, selection, and implementation of technology, systems, and tools related to submission planning, publishing, assembly, and archiving.
• Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities. Consults with other groups to ensure consistency in processes and procedures for documents destined for regulatory submissions. Updates internal processes to ensure compliance with health authority requirements and expectations.
• Develop and maintain document templates (e.g., eCTD content and structure per ICH guidelines) and internal style guides for documents to be submitted in regulatory filings.

• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
• Some international travel may be required
• Other duties as assigned

QUALIFICATIONS:

• Bachelor’s degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or contract research organization (CRO), including experience in project coordination and document management systems and processes. A combination of degrees and experience will be considered.
• A minimum of 5 years’ management level experience in a pharma or biotech environment.
• Experience with pharmaceutical regulatory submissions (specifically, eCTD) and supporting regulatory filings, such as annual reports, IND/CTA or NDA/MAA.
• Understanding of the drug development process, FDA/EMA regulations and ICH guidance.
• Expert proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat.
• Hands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissions.
• Familiarity with eCTD publishing software.
• Understanding of best practices for regulatory filing planning; ability to create and manage an accessible and reliable system for regulatory document retrieval and archiving. 
• Demonstrate strong initiative and drive. Must be organized, highly collaborative, and able to problem-solve and anticipate departmental needs.
• Ability to work successfully in cross-functional teams. Strong interpersonal and communication skills.

The base salary range for this role is $144,500 to $182,700 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.