Senior Manager, Regulatory Affairs (Clinical)

We are seeking a Senior Manager, Regulatory Affairs to join our team. This role will develop, propose and implement well-informed global regulatory strategies in a highly cross-functional, collaborative, project team environment. The Senior Manager will provide regulatory support for clinical studies (as assigned) with the objective to obtain regulatory approvals for the initiation of clinical studies, as well as any amendments and maintenance activities for the continued conduct of clinical studies.

The ideal candidate will be an independent and self-directed team player with strong communication and influencing skills. This individual will also be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research organizations (CROs), and other vendors as required.

This position reports to the Director, Regulatory Affairs and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

• Provide Regulatory support on multidisciplinary project/clinical study teams provide input on the documentation and procedural requirements as defined by regulatory authorities including: submission delivery strategy, reviewing of documents and analysis of procedures used during development. Lead some aspects of strategy and support others depending on complexity.
• Work with business partners, external experts, CROs and internal colleagues, to align on global regulatory strategy and coordinate regulatory submissions.
• Create, review, contribute and edit submissions to support development including US Investigational New Drug (IND) submissions, Canadian and/or EU Clinical Trial Applications (CTAs), New Drug Application (NDA) and other global submission documents in conformance with regulatory requirements and strategies to ensure high quality and timely submissions.
• Support multidisciplinary team preparing responses to regulatory agency questions during the IND and CTA review phases for assigned projects.
• Provide support to prepare project teams for FDA and other regulatory agency meetings, as required.
• Actively participate as a member of global regulatory teams and cross-functional project teams.
• Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.
• Maintain knowledge of global competitive landscape, regulatory environment, regulatory agency regulations and guidelines, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed.
• Occasionally travel internationally for meetings and conferences may be required.
• Other duties as assigned.

QUALIFICATIONS:

• A Bachelor’s, Master’s, PharmD or PhD in a scientific, medical or regulatory discipline.
• A minimum of 5 years’ management level experience in a pharma or biotech environment. Job level commensurate with years of experience.
• Special knowledge, skills and/or licenses or certificates preferred, such as Regulatory Affairs Certification (RAC) highly desirable.
• Demonstrated track record of successful regulatory submissions and strategies in Canada, US, and Europe required.
• Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
• Ability to develop global risk assessment scenarios prior to functional and team reviews.
• Ability to influence without direct authority.
• Ability to build trust and respect within the organization.
• Balance strategic thinking and strong analytical skills with the ability to execute.
• Detail oriented with excellent written and verbal communication and presentation skills.
• Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 
• Proficiency with Microsoft Excel, PowerPoint, Project and Word programs.

The base salary range for this role is $141,600 to $179,100 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.