Regulatory Affairs Lead
Philadelphia, PA 
Share
Posted Today
Job Description

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 Lead, under general guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA, EMA and other health authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions may include INDs/CTAs, amendments, annual reports, DSURs, briefing documents, orphan drug applications, and additional documents as needed. He or she will interact effectively with cross functional team members in order to coordinate documentation required for submissions, ensuring timelines are met, have direct interaction with regulatory agencies on defined matters, and contribute to development of regulatory strategy.


Responsibilities

60%

  • Manage all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
  • Lead functional groups across the organization in the development of relevant data to complete regulatory submissions.
  • Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
  • Manage activities to maintain regulatory filings including planning and preparing BLA amendments, IND/CTA amendments, annual reports, DSURs etc.
  • Lead the development of briefing documents for formal regulatory meetings.
  • Provide regulatory guidance to cross-functional teams.
  • Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
  • Initiate and contribute to local process improvements which impact various functional groups
  • Develop and maintain cooperative relationships as the point of contact with partners and regulatory health authorities
  • Contribute to the development of ex-US regulatory submissions

Responsibilities Continued

30%

  • Manage the development of regulatory processes to manage pre-approval compliance activities.
  • Support the development of regulatory processes for submission planning and management.

10%

  • Other projects and duties may be required.

Requirements

  • BS in Life/Health Sciences required, graduate degree preferred.
  • Minimum 4-6 years experience or 2-4 with a MS/PhD in a Regulatory Affairs
  • Pharmaceutical or related environment with biologics experience preferred.
  • Working knowledge of all FDA requirements pertaining to submission of regulatory documents
  • Demonstrated ability to coordinate submissions independently in a time intensive situation

Competencies

  • Knowledge of the drug development process, with a focus on IND/CTA and BLA/MAA processes.
  • Demonstrated experience in preparing IND and/or BLA submissions is required.
  • 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.
  • Excellent interpersonal communication and organizational skills
  • Possesses strong critical and logical thinking
  • Demonstrated strong writing and communication skills
  • Strong attention to detail

Competencies Continued

  • Demonstrated ability to work both independently and in a team environment
  • Demonstrated ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines)
  • Highly flexible, adaptable, and experienced in a fast-paced environment
  • Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
  • Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts
  • Demonstrates excellent verbal and written communication skills.

#LI-AA1

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
4 to 6 years
Email this Job to Yourself or a Friend
Indicates required fields