The Portfolio Manager, Regulatory Affairs will be responsible for assisting in the development and implementation of regulatory activities leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, provide operational input to cross-functional teams responsible for global programs.
The person will be responsible for leading and managing regulatory submission deliverables such as INDs and amendments, CTAs and amendments, NDAs/BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Work with cross-functional teams to develop submission plans (table of contents, timelines, and responsibility matrices) for across the company’s portfolio of all regulatory submission including, but not limited to, original applications, major amendments, and marketing applications.
Participate in kickoff and other cross-functional meetings related to submissions, such as, working group meetings related to submission documents and document review resolution discussions.
Present submission timeline plan at appropriate regulatory submission planning meetings
Facilitate meetings to discuss timeline mitigation plans for delayed activities
Coordinate development of submission documents, resourcing, and timelines across the company’s portfolio Assist with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance
Assist with regulatory inspection activities
Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
eCTD knowledge and project management skills.
Can work independently, ability to multitask, self-motivated, well organized and adaptable, detail-oriented, able to prioritize, work well with others, work effectively under pressure, and has excellent written and verbal communication skills.
May be responsible for supervising others
* Minimum level of education and years of relevant work experience.
At least a BA or BS, higher degree is preferable.
* Special knowledge or skills needed and/or licenses or certificates required.
Working knowledge of MS Project and electronic document management systems (eg, Veeva and SharePoint) is desirable, as is working knowledge of MS Office applications and Adobe Acrobat.
* Travel requirements
Office-based position (optionally remote)
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.