Job Description Summary:

The Senior Manager, Global Clinical Regulatory Lead, is responsible for providing strategic and operational direction for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the US as applicable. This role includes responsibility for support of global clinical trials, regional registrations and life cycle management regulatory activities. This individual supports the Global Regulatory Lead on their assigned products. This position collaborates with others in the Regulatory Affairs Strategy team, Regulatory Subteams, and potential cross-functional teams on assigned projects.

The role is responsible for overseeing the IND submission in the US, as well as for clinical trials applications for the rest of world. Additionally, this role supports the GRL to ensure that regional regulatory strategies are executed in compliance with current, applicable regulations and standards.

This position works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers.

The Senior Manager, Regulatory Affairs US ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:

• Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.
• Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC's commercial/business objectives.
• Provides regulatory support to the Global Pharmacovigilance (PV) organization and regional/country representatives as necessary to ensure that PTC's PV obligations within the region are met.
• Perform other tasks and assignments as needed and specified by management.
• Works closely with GRL in the preparation of Global Regulatory Strategy for assigned projects:
  • Maintain current knowledge of relevant regulations, including proposed and final rules as well as updated regulatory guidance's
  • Prepare global regulatory strategy for drugs and gene therapies through conducting research, preparation of labeling documents, and additional regulatory submissions.
  • Analyze clinical, non-clinical and CMC development work in context with global regulatory guidance to develop global regulatory strategies.
  • Prepare CCDS (company core data sheet), US-PI and SmPC
  • Prepare and review regulatory submissions for domestic or international projects, such as Rare Pediatric Disease Designation (RPDD) applications, Orphan Drug Designation (ODD) applications, Annual Reports, and Development Safety Update Reports (DSURs), Scientific Advice briefing books, pre-IND, IND, Briefing Books, and MAA/BLA/NDAs
  • Performs other tasks and assignments as needed and specified by management.

Clinical Trial Applications (CTAs):

• Initiate and execute CTA/CTNs in US, EU, and globally by keeping up to date with regulations and critically analyzing the interactions with health authorities to ensure that any outstanding issues are addressed
• Liaise and attend essential meetings between Contract Research Organizations (CROs) and PTC regulatory team to retrieve documents as needed for submissions to Health Authorities internationally.
• Align with CROs, IRL and GRLs on timelines for development and submission of CTAs

Qualifications:

• Bachelor's degree in life science field and a minimum of 5 years experience in the Pharma/Bio Industry, an MS, PhD, or PharmD with a minimum of 3 years of experience in Regulatory Affairs.
• Knowledge of relevant, regional regulatory guidelines and requirements with the ability to interpret these as it applies to assigned projects.
• Demonstrated, hands-on experience managing and submitting clinical trial applications, leading the activities to support responses to queries from health agencies across all phases of development.
• Ability to support the Global Regulatory Lead as requested, with research and selected tasks outside of clinical trial filings.
• Demonstrated track record of successfully building stakeholder relationships with cross-functional teams
• Excellent verbal and written communication
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, 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.
• Ability to influence without direct authority.
• Fluent in English (verbal and written). Other languages considered an advantage.

Travel requirements: Up to 5% travel

This is a hybrid role to Warren, NJ

Expected Base Salary Range:

$130,000 - $164,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

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