Regulatory Affairs CMC at Biopharmaceutical Company in Boston, Massachusetts, United States —
- bio Pharmaceutical
- Biopharmaceutical Company
- Boston, Massachusetts, United States USA
- 1/19/21 2021-01-19
Job ID: 1631633
We are seeking an experienced and motivated Regulatory Affairs, CMC (Chemistry, Manufacturing & Control) leader who possesses operational/tactical and strategic experience with CMC activities for small molecule compounds from late-stage discovery through regulatory filings and commercialization. Reporting to the to the Vice President of Regulatory Affairs and Quality Assurance, the incumbent will be responsible and accountable for phase-appropriate CMC strategies and operational activities in support of our development programs. The position interacts directly with various groups within the company and externally (CDMOs, consultants, subject matter experts), and will be a key member of matrixed project teams. The position will maintain submission-planning timelines for assigned projects and will develop and implement submission strategies.
- Provide operational, tactical and strategic regulatory CMC expertise and direction to project teams. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation.
- Ensure the application and institutionalization of global CMC regulations and guidance and engage with regulatory and KOLs I the external environment to develop new CMC policy.
- Define the CMC content of regulatory submissions, and author, review and approve regulatory CMC documents on behalf of Regulatory Affairs for assigned projects.
- Collaborate with RA colleagues and external vendor to affect submissions to regulatory authorities.
- Lead the formulation of responses to CMC-related queries from regulatory authorities. Work with project teams to develop responses and ensure timely response to health authority inquiries.
- Ensure that the documentation provided in regulatory submission is fit for the intended purpose, and of enough quality to support the regulatory filing, that the electronic records in internal documentation systems are accurate and complete.
- Carry out main role responsibilities, ensuring compliance with Corporate Responsibility policies.
Qualifications and Skills:
- MS, PharmD or PhD in a scientific discipline, typically chemistry, pharmacy, pharmaceutics, or biological sciences.
- 5-10 years prior experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacturing may partially substitute.
- Advanced technical skills and significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacturing.
- Significant experience in regulatory submissions in the global environment, i.e. eCTD.
- Experience with NDA approvals a strong plus.
- Expertise in implementation of and effective utilization of RIM systems, including development of SOP’s and training programs.
- Highly motivated, decisive and results-oriented individual with flexible attitude.
- Has the creativity to excel in and contribute to a rapidly growing company.
- Knowledge of Veeva is a plus.
- Broad experience in a small company environment is a plus.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Proven ability to manage multiple projects, identify and resolve issues.
- Broad experience in a small company environment is a plus