Job description
Reporting to the Vice President, Regulatory Affairs, the Director of CMC Regulatory Affairs will be responsible for developing and implementing CMC regulatory strategies as well as coordinating all aspects of CMC regulatory submissions. This person will represent the function of CMC regulatory on project teams within Ironwood as well as serve as the regulatory CMC liaison with partners on development projects and commercial products.
Responsibilities:
Develop the function of CMC regulatory;
Develop and implement CMC regulatory strategies for investigational, and ultimately, commercial drug products;
Lead activities, including planning, writing and reviewing CMC (chemistry, manufacturing and control) sections of all regulatory submissions (INDs, NDAs, CTXs, meeting requests, and briefing documents) to support clinical trials and product registration. This will require the development and management of project timelines;
Coordinate the preparation of responses to regulatory agencies;
Act as primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues ;
Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;
Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic;
Assess post-approval changes for existing commercial products and provide guidance on regulatory impact.
Requirements:
A minimum 4-year degree in Chemistry, Biochemistry, or related pharmaceutical science required; advanced degree desirable;
10 years of industry experience in pharmaceutical product development, with a minimum of 5 years in Chemistry, Manufacturing and Control (CMC) regulatory environment;
Excellent communication and interpersonal skills ;
Work well with employees across the entire organization;
Discerning and intuitive regarding how to best use your talents and the talents of your team with an ability to work under tight deadlines;
Solid working knowledge of drug development process and in-depth knowledge of FDA regulatory requirements; EU, Canada, and ROW experience desirable;
Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities;
Strong knowledge of current Good Manufacturing Practices (cGMP).
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