Regulatory Affairs CMC Lead

Highly Competitive Salary
  1. Permanent
  2. Project Manager, Publishing & Submissions, CMC
  3. United States
North Chicago, USA
Posting date: 09 Sep 2020
RA.ZH.31693

Proclinical is currently recruiting for a Regulatory Affairs CMC Lead with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

  • Identifies and collects data needed and prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions.
  • Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new clinical applications and amendments, market applications, renewals, annual reports, supplements/variations under limited supervision. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
  • Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
  • Develops strategies for CMC meetings, support/manage preparation for agency meetings and content of pre-meeting submissions.
  • Regularly informs regulatory management of important timely issues.
  • Represents CMC regulatory affairs on teams such as the product development and Global Regulatory Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions.
  • Supports combination products and medical devices including design control and change management activities

Skills and Requirements:

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related
  • 8 years pharmaceutical or industry-related experience. Some portion should include experience related to pharmaceutical regulatory work. Proven 3+ years in a leadership role with strong management skills.
  • Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
  • Strong communication and proactive negotiation skills, both oral and written.
  • Experience interfacing with government regulatory agencies.
  • Experience developing and
    implementing successful global regulatory strategies.

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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