Regulatory Affairs, CMC (Manager-Senior Manager)
33 Arch St, Boston, MA 02109 Boston, MA 02109 US
Position: Regulatory Affairs, CMC (Manager-Senior Manager)
Extremely well funded and rapidly growing late stage biotech company focusing on neurological conditions, is seeking an experienced and motivated Regulatory Affairs, CMC (Chemistry, Manufacturing & Control) individual 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 Associate Director of Regulatory Affairs, CMC, the incumbent will be responsible and accountable for phase-appropriate CMC strategies and operational activities in support of 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.
- Independently prepare CMC content of regulatory submissions, such as INDs, NDAs, and other regulatory documents.
- Collaborate with RA colleagues and external vendor to effect submissions to regulatory authorities.
- Coordinate responses to CMC-related queries from regulatory agencies.
- Ensure that the documentation provided in regulatory submissions is fit for the intended purpose, and of sufficient quality to support the regulatory filing, and 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
- Bachelor’s degree in a scientific field is required; MS, PharmD or PhD in a scientific discipline, typically chemistry, pharmacy, pharmaceutics, or biological sciences, is preferred.
- 5+ years’ experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, or Manufacturing; 3+ years prior experience in Regulatory Affairs with focus on CMC may partially substitute.
- Significant experience in regulatory submissions in the global environment, i.e. eCTD.
- Experience with NDA approvals a strong plus.
- Highly motivated 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.
- Proven ability to manage multiple projects, identify and resolve issues.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
- Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
- Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
- Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.
- Broad experience in an emerging, publicly traded company environment is a plus.
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