Regulatory Affairs Specialist

Ironwood Pharmaceuticals; Boston (MA); Hybrid; USD 202,000 - 237,000; Full time

Job summary

A leading global GI healthcare company seeks a Director of Regulatory Affairs CMC to lead regulatory activities supporting product development strategies. The role involves collaboration with senior leadership and managing global regulatory submissions. The ideal candidate will have extensive experience in CMC regulatory affairs and a proven track record in drug development.

Benefits

Restricted Stock Unit awards

Bonus or sales incentive program

401(k) with matching contributions

Medical, dental, vision, and prescription drug benefits

Wellness stipends

Generous vacation/holiday schedule

Qualifications

• Minimum 10 years in CMC Regulatory Affairs within biopharmaceuticals.
• Experience in successful submission and approval of market applications.
• Global post-approval experience for life-cycle management.

Responsibilities

• Lead CMC regulatory strategy for assigned programs.
• Provide global regulatory guidance to project teams.
• Manage interactions with health authorities.

Skills

Leadership

Communication

Project Management

Teamwork

Education

Bachelor’s degree in Biology, Chemistry, or Pharmaceutical Sciences

Advanced degree

Tools

Computer skills

Project management skills

Job description

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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.

Purpose/Summary:

Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company’s product development strategies and providing guidance to broader CMC functions. This individual will ensure all applicable global CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans. This individual will work collaboratively with senior leadership and key stakeholders to develop global CMC regulatory objectives for one or more programs, lead the preparation and filing of global regulatory CMC submissions and manage the preparation for interactions with Health Authorities. The Director will be effective in collaborating within the organization and provide leadership by communicating, executing, and providing guidance to team members toward achieving the department/corporate objectives.

Essential Functions:

• Lead the development of CMC regulatory strategy for assigned programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle
• Serve as the regulatory representative at internal CMC team meetings, core submission meetings and other cross functions meetings.
• Provide global regulatory Affairs-CMC strategic guidance to project teams and ensure timely development and execution of project plans.
• Assess and communicate CMC regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction
• Initiate and lead discussions with health authorities to proactively obtain scientific advice/agreement and resolve CMC issues in a timely manner.
• Facilitate the preparation for CMC-focused meetings with FDA, EMA, PMDA or national competent authorities, and participate in or lead the interactions with these agencies
• Support Quality and tech ops during GMP inspections
• Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and global CMC regulatory submissions (e.g., original INDs, CMC amendments, IMPD Amendment, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development
• Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success
• Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines
• Coordinate and conduct global CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required
• Keep appraised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities
• Coordinate with appropriate team members and stakeholders to resolve outstanding CMC regulatory issues

Requirements:

• Bachelor’s degree in a field of science such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred but not required.
• A minimum of 10 years of increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry is required.
• Prior experience in successful submission and approval of market applications is required.
• Candidates must have global post-approval experience for life-cycle management of products
• Candidates must have proven strategic development capabilities related to new drug development and commercial support activities.
• Demonstrated recent successful global Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and internationally.
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
• Demonstrate excellent teamwork and communication skills with the ability to impact and influence the decisions of a team.
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong oral and written communication, time management, and team-oriented leadership skills are essential
• Excellent computer and project management skills are essential for the successful candidate.
• Ability to work in a fast paced-environment and to handle multiple tasks.

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Ironwood currently anticipates that the initial base salary for this position could range from between $202,000 to $236,040. 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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Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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