Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC, you will work closely with cross-functional teams, CMOs, and Health Authorities. This company offers a science-based, entrepreneurial culture, excellent employee benefits, and flexible work arrangements. With their lead program going into global Phase three studies this year, now is an exciting time to join this growing organization!
Responsibilities:
- Provide regulatory CMC strategic leadership to support development of multiple innovative products including life-cycle management and post-marketing changes.
- Prepare and submit high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (NDAs/MAAs).
- Lead CMC-specific meetings and resolve CMC issues through negotiations with regulatory agencies.
- Review and approve CMC technical reports as source documents, as per procedures, in coordination with Quality.
- Develop CMC response strategies and submissions to health authorities.
- In coordination with Regulatory Operations, manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality.
- Lead the preparation for CMC meetings with health authorities and develop CMC section of briefing packages.
- Shepherd proactive interactions with regulators; prepare and submit responses to CMC questions.
- Support R&D and the Quality Group with regulatory agencies during cGMP and pre-approval inspections.
- Provide critical review of all CMC information supporting regulatory applications, including CMC sections of Investigators’ Brochure, SmPC, and labeling.
- Assess proposed change controls (e.g., manufacturing process changes) and provide strategic regulatory guidance to enable regulatory and filing implementation.
- Identify and assess CMC regulatory risks on key program strategies.
- Prepare and deliver effective presentations for internal and external audiences.
- Ensure productive interactions between Regulatory CMC, R&D, Quality, and Technical Operations, along with business partners and CMOs.
- Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs.
Qualifications:
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- Eight or more years in CMC Regulatory for small molecule pharmaceutical drugs.
- Experience with drug-device combinations products (e.g., pre-filled syringes and injectables) and ophthalmic products highly desired but not required.
- Must have regulatory CMC experience supporting both development projects and commercial products.
- Experience writing CMC sections for INDs, CTAs, NDAs and supportive amendments or supplements.
- Must have experience working directly with the FDA. Experience with global regulatory authorities (EMA, Health Canada, etc) a plus.Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
- Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations and guidelines including ICH, and FDA guidelines
- Proficient in Microsoft Office Suite (Outlook, Teams, Word, etc.) and other applications (e.g. Adobe Acrobat and eCTD viewers).
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
- Strong written and oral communication skills.
- Detail oriented and well organized. Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Independently motivated and solution oriented.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Able to be flexible and comfortable with ambiguity.
This is an onsite position in the Greater Boston Area. This individual must be onsite 2-3 days a week.
The budgeted salary range for this position is US$150,000 to $225,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.