Regulatory Affairs Associate

Job Description

Job Description

Description:

• Responsible for managing and compiling CMC sections of marketed product variations.

• Partner with RA CMC Project Leads and develop module 3 content and project timelines.

• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.

• Skills for running review meetings for submission documents.

• Understand CMC expectations including CTD content, structural and formatting requirements.

• Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.

• Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.

• This position will coordinate activities with all functional departments in support of regulatory filings.

• Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

• Review and approval of manufacturing changes for Class III implantable medical devices.

• Relies on extensive experience and judgment to plan and accomplish goals.

Qualification:

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline

• Required Experience: 4 years pharmaceutical. 1-2 years cross functional project management

• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)

• Superior oral and written communication skills

• Ability to work cooperatively with all levels and types of global personnel required

• Experience working with electronic document management systems

• Ability to work independently. Manage multiple projects simultaneously.

• Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.

• Detail/accuracy oriented, collaborative and willing to learn

• Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.

• May require an advanced degree and 3 to 5 years of direct experience in the field. Recent experience with Class III implantable medical devices

• Familiarity with US and other international regulatory requirements for dossiers

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

\nCompany Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities