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Job Title: CMC Manager/Associate Director, Regulatory Affairs


		Ironwood Pharmaceuticals 320 Bent Street Cambridge 02141 www.ironwoodpharma.com

	Ironwood Pharmaceuticals (formerly Microbia) is an entrepreneurial pharmaceutical company dedicated to the art and science of great drugmaking. The Company is advancing several clinical candidates—linaclotide for the treatment of irritable bowel syndrome with constipation, chronic constipation and other functional gastrointestinal disorders; and novel, next-generation cholesterol absorption inhibitors for the treatment of hypercholesterolemia. Ironwood also has a growing pipeline of additional drug candidates in earlier stages of development. Microbia Precision Engineering, Inc., a majority-owned subsidiary of Ironwood Pharmaceuticals is an industrial biotechnology company developing and commercializing novel bioprocesses for the production of specialty chemicals. Ironwood has raised $231 million in private equity financing and is located in Cambridge, Massachusetts.

Job Description:

Reporting to the Senior Director, Regulatory Affairs, the candidate will be responsible for developing and implementing CMC regulatory strategies as well as coordinating all aspects of CMC regulatory submissions. This person will serve as the regulatory CMC representative on project teams and be involved with products throughout their life cycle.

- 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;

- Access 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.

- 4-year degree in chemistry, biochemistry, or related pharmaceutical science required; advanced degree helpful;

- 5 years of industry experience in pharmaceutical product development, with a minimum of 3 years in preparing and supporting chemistry, manufacturing and control (CMC) documentation for regulatory filings;

- 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 knowledge of FDA regulatory requirements; E.U., 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).

Job Location(s):

Cambridge,MA,US

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