Contract, Regulatory Affairs

Summary
PTC is an established global biopharmaceutical company that delivers transformative therapies for people living with rare diseases. For 25 years, we have been harnessing our scientific platforms to create new therapies that address the underlying cause of the disease and deliver on our promise to create more moments for those who count on us.
The Regulatory Affairs Contractor - MEA ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities of the role include:

• In alignment with PTC’s global regulatory strategies, assists in the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.
• Serves as a liaison to regional regulatory Health Authorities including national authorities and provides guidance and advice on regulatory and policy developments within the region to PTC’s global regulatory team and other key stakeholders. Actively maintains knowledge of regional regulatory requirements (e.g. new regulations, laws, etc.).
• Supports strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: Clinical Trial Applications (CTAs); Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals) and customized dossiers for the registration of drug products in countries within the region.
• Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs.
• Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.
• Ensures that drug products distributed with 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.
  
• Contributes to the organizational design of the regional regulatory affairs function and contributes to 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.
• Performs other tasks and assignments as needed and specified by management.
  

Requirements For The Role Include

• Bachelor’s degree in a relevant discipline and a minimum of 7 years of progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment with at least 2 years of leadership experience in a regional Regulatory Affairs role.
• Prior experience helping to build a regional Regulatory Affairs function for a growing organization.
• In-depth knowledge of relevant, regional regulatory guidelines and requirements.
• Demonstrated, hands-on experience managing and preparing all phases of regional/country-specific regulatory submissions including knowledge of National, Mutual Recognition and Decentralized/Centralized procedures.
• Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
• Demonstrated success gaining regional regulatory approval and in providing regulatory support for post-marketing and life cycle management activities such as variations, renewals and labelling.
• Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities.

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  Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and 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.
• Fluent in English (verbal and written).
• *Special knowledge or skills and/or licenses or certificates preferred.
• Experience in Genetic Disorders, Central Nervous System (CNS), Infectious Disease or Oncology Therapeutic Areas.
  

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.
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