Associate Specialist - Regulatory Affairs; Hybrid

Position: Associate Specialist - Regulatory Affairs (Hybrid)
** Job Description*
* The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions.

** _This position is based at the Philadelphia, PA, WeWork Office, on a hybrid bases- 3 days in office;
The incumbents will be required to commute to the Philadelphia, PA, WeWork Office, for these 3 days._*
* ** The responsibilities of the incumbent may include the following:*
* + Maintain accountability for use of established planning and tracking practices and systems.

+ Participate in pilots for new tools and processes.

+ Collaborate with colleagues inside and outside of the department, as appropriate.

+ Participate in training courses to increase job role skills and regulatory knowledge.

** Program:*
* + Support in the creation of FDA cover letters and forms, creation of submission plans, assist in tracking deliverable timelines of components, and archiving in systems.

** Shared Services:**  (Regulatory Submission Specialist)

+ Provide regulatory submission/systems support.

+ Manage regulatory documents, assisting in tracking timelines/deliverables and/or components and promptly responding to updates.

** Education Minimum Requirement:*
* + High School Diploma or equivalent.

** Required Qualifications,

Skills & Experience:

*
* + Ability to communicate effectively, both verbally and written with others across cultures and organizational levels.

+ Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role.

+ Familiar with computer systems (MS Office necessary; Advanced Excel and Word skills preferred).

+ Highly organized individual with keen attention to detail.

** Desired Experience &

Skills:

*
* + Demonstrated leadership.

+ Takes initiative.

+ Ownership of deliverables.

MSJR

*
* Required Skills:

*
* Accountability, Communication, Computer Literacy, Customer Satisfaction, Deliverables Management, Document Control Systems, Independent Thinking, Microsoft Word, Taking Ownership, Working Independently

** Preferred

Skills:

*
* Project Management

Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://(Use the "Apply for this Job" box below). EEOC Know Your Rights  10 20.pdf)

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts ()

The salary range for this role is

$71,900.00 - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and…