Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.
Position Summary:
Lead the Regulatory Affairs CMC function supporting process development and the manufacturing of drug substance, drug product, and devices through successful regulatory filings and ongoing commercialization compliance. Serve as an internal subject matter expert for the application of all relevant global health authority regulations and guidance documents for our internal teams working with contract development manufacturing organizations (CDMOs) and testing labs to ensure the highest integrity in regulatory and quality compliance. Engage with global health authorities to gain alignment on requirements and advance filings.
Major Responsibilities:
- Lead the Regulatory Affairs-CMC function and set the long-term regulatory strategy for all products throughout all phases of product life cycle with the aim of optimizing the regulatory path and obtain rapid approvals from health authorities.
- Provide Regulatory Affairs-CMC strategic guidance to project teams and ensure timely development and execution of robust global regulatory strategies, regulatory risk assessments, and mitigation plans either directly or through delegation to staff/contractors.
- Prepare and submit high-quality regulatory CMC submissions and oversee all technical writing of the submissions either directly or through delegation to staff/contractors. This should be performed in collaboration with Technical Operations, Quality, and Regulatory Affairs functions to meet company and project goals; ensure CMC‐related documents are complete, fit-for-purpose, and meet all relevant regulatory requirements.
- Work cross-functionally with Technical development, quality and regulatory colleagues to initiate and lead discussions with health authorities to proactively obtain scientific advice/ agreements and resolve CMC issues in a timely manner.
- Lead regulatory CMC intelligence activities, provide counsel, training, and interpretation of FDA, EMA, and other health authority feedback, policies, guidelines to company personnel.
- Support the development and implementation of fit-for-purpose policies, procedures, and systems to ensure compliance with CMC regulatory requirements in regulatory regions of interest for all products throughout all phases of product life cycle.
- Support Quality and CMC team(s) during GMP inspections.
Qualifications:
- Bachelor’s degree in a Life Sciences discipline or equivalent, advanced degree preferred.
- 10-15 years of biopharmaceutical experience with at least 5-10 hands-on Regulatory Affairs-CMC experience and at least 5-10 years managing direct reports.
- Thorough understanding of relevant regulations and guidelines, including ICH, FDA, and EMA guidelines, for the development of small molecule drugs, biologics, and drug-device combination products.
- Regulatory Affairs-CMC experience in all stages of development for small molecules, peptides, biologics, and combination products.
- Recent experience in successfully submitting and obtaining approvals for global marketing authorization applications, including successfully leading CMC‐related health authority interactions.
- Strong knowledge of current Good Manufacturing Practices (GMP).
- Strategic thinking with strong analytical and project execution skills.
- Detail oriented and results driven with strong written, verbal communication, and presentation skills.
- Strong interpersonal and influencing skills; ability to influence without authority and proven experience in building and cultivating strong relationships with key partners and stakeholders, both internally and externally.
- Ability to work effectively in a matrix environment (project/function) and in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Proven ability to develop and manage Regulatory Affairs-CMC team(s) focused on accountability and meeting/exceeding expectations.
Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Ironwood currently anticipates that the initial base salary for this position could range from between $256,000 to $298,095. The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.
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