Responsibilities:

• In alignment with PTC's global business objectives, oversee development and implementation of regulatory strategies throughout all stages of clinical and commercial development of drugs and biologics.
• Collaborates with internal and external key stakeholders as appropriate to ensure effective registrations for the product, while also supporting PTC's clinical development and commercial/business objectives.
• Provides regulatory support and oversight for country specific Early Access Programs (EAPs). This may also include assistance with the preparation of supportive regulatory documents for these programs.
• May serve as a liaison to country and/or regional regulatory Health Authorities including the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other national authorities.
• Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: clinical trial applications; Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals) and customized dossiers for the registration of drugs and biologics in a compliant and timely manner.
• 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.
• Contributes to the organizational design of the regional regulatory affairs function and plays a lead role in the selection of resources (employees and/or contractors) required to meet departmental and corporate objectives; supports the co-ordination of contracted activities for translation, submission of regulatory documentation and contact with local Health Authorities.
• In partnership with other regulatory affairs staff, maintains and develops knowledge of global regulatory requirements (e.g., new regulations and laws) that affect the further clinical development and commercialization of Translarna.
• Manages, coaches and mentors direct and indirect reports.
• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• MS degree in a scientific discipline required. Advanced degree (PharmD or PhD) highly desirable, and a minimum of 10 years of progressively responsible experience in Regulatory Affairs in a rare disease pharmaceutical, biotechnology, contract research organization (CRO) or related environment. Position also requires a minimum of 3 years of leadership experience in a global regulatory affairs role.
• Prior experience leading a Regulatory Affairs function, including the associated staff, for a growing organization, ideally combining a mix of large company best practices and smaller company adaptability.
• In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US, European regions and Japan.
• Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
• Demonstrated record of success in gaining regulatory approval of NDA, BLA and MAA for rare disease treatments in the US and in Europe.
• Hands-on experience in all phases of regulatory submissions and direct experience interacting with FDA, EMA and other national health authorities. Direct contact and negotiation experience with such health authorities.
• Experience with Clinical Trial Applications (CTAs), PIPS and post-marketing/life cycle management (e.g., variations, renewals, labeling).
• Experience with non-clinical, Chemistry, Manufacturing and Control (CMC) related regulatory matters.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• 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.

Travel requirements: 10-25%

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.