Share this Job

Regulatory Affairs Leader

Date: Nov 21, 2018

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Summary

The Regulatory Affairs Leader will lead the preparation of submissions, which may include INDs/CTAs, Briefing Documents, Orphan Drug Applications, Pediatric Plans, Marketing Applications, etc. Implicit is the ability to work with cross-functional teams to define contributions to submissions and lead submission teams for projects assigned. He or she will develop, coordinate and implement regulatory, research and administrative processes essential to successful management of gene therapy clinical trials and other supporting non-IND efforts. The lead will recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance and keep abreast of regulatory procedures and changes. A person in this position will have direct interaction with regulatory agencies on defined matters. He or she will recommend strategies for earliest possible approvals of clinical trial and marketing authorization applications and combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured and/or distributed to meet required legislation worldwide. 

Responsibilities

45%

• Lead all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and approval requirements. Lead functional groups across the organization in the development of relevant data to complete regulatory submissions. 

• Lead the preparation and maintenance of Clinical Trial Application dossiers, e.g. Investigational New Drug (IND) and Investigational Medicinal Product Dossiers (IMPDs) as applicable.

• Lead the filing teams and assist with preparation and maintenance of product authorization applications, e.g. MAA, BLA as applicable.

• Monitor applications under regulatory review; communicate application progress. 

• Lead responses to objections/questions issued by Regulatory Authorities/Agencies.

• Lead preparation, submission and follow-up of Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, etc. 

• Report adverse events and other unanticipated problems to regulatory agencies and internal stakeholders.

• Responsible for accuracy and content of communications

• Support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle. 

• Provide regulatory guidance to cross-functional teams for project and product lifecycle planning. 

• Work effectively with regulatory colleagues specializing in other functional areas to continuously improve regulatory systems, teamwork, and efficiency. 

 

45%

• Support the development of regulatory strategies and plans to advance Spark products through the regulatory review and approval process globally.  

• Prepare for and attend as needed meetings with regulatory authorities 

• Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.  

• Evaluate proposed nonclinical, clinical, and manufacturing changes for regulatory filing strategies.

• Participate in the development & implementation of new regulatory policies, processes, systems, and SOPs and train key personnel on them.

 

10%

• Other projects and duties as may be required

Qualifications

• Thorough knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes.

• Demonstrated experience in preparing new IND submissions.  Experience with BLA submissions is desirable.

• Excellent writing skills with an ability to write detailed information for submissions.

• Excellent ability to read, analyze and interpret technical documents, technical procedures and government regulations.

• Prepare and deliver effective presentations for external and internal audiences. 

• Knowledge of computers and appropriate software packages. Experience with electronic submissions preferred. 

• Ability to handle multiple tasks and strong attention to detail.

• Excellent interpersonal communication and organizational skills. 

• Successful performance in a high-intensity work environment.

• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.

• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations. 

• Current knowledge and understanding of Ethical guidelines of clinical research and the regulatory process.

Requirements

• Bachelor’s degree in Life/Health Sciences required; advanced degree preferred.

• Generally has 12 years or related experience or an advanced degree with 7 years of experience (e.g. regulatory, healthcare, and/or clinical research experience)

• At least 7 year’s experience preparing regulatory submissions

• Experience in Spark’s targeted disease areas preferred (Retina, Hematologic, Inherited Metabolic Diseases, CNS)


Nearest Major Market: Philadelphia

Find similar jobs: