Regulatory Affairs Associate

Description

• The Senior Associate, RA CMC works with internal and external partners in order to deliver products to patients.
• Prepares CMC regulatory strategies that enable first pass approvals under management supervision.
• Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations under management supervision.
• Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.
• Represents RA CMC on product development and life-cycle management teams.
• Prepares CMC regulatory submissions under management supervision.
• Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations under management supervision.
• Analyzes and interprets information, that impacts regulatory decisions.
• Seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under management supervision.
• Responds to global regulatory information requests under management supervision and regularly informs regulatory management of important timely issues.
• Manages products and change control with an understanding of regulations and company policies and procedures under management supervision.
• Analyzes and approves manufacturing change requests under management supervision.
• May represent CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in the regulatory climate.
• Maintains awareness of legislation and current developments within specific area of business
• Working with technical team to prepare regulatory filing dossiers
• Potentially assessing changes for regulatory impact
• Document management system responsibilities
• Attend GRPT as needed
• Attend Operations Brand Teams as needed
  
  

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Relevant advanced degree preferred. Certification a plus.
• 1-2 years in quality systems or cross functional project management
• 2-4 years CMC Regulatory experience
• Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
• 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing preferred
• Experience working in a complex and matrix environment
• Strong oral and written communication skills
  
  

Preferred Experience

• US/ EU Post approval variation support
• Change Management Experience
• International Regulatory Strategy for on market products
  
  

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 enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.