SUMMARY:Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.
ESSENTIAL FUNCTIONS: - Serves as regulatory CMC representative on development and marketed product teams.
- Responsible for advising teams on regulatory authority expectations and guidelines and ensure the CMC regulatory strategy is in alignment with the global strategy and with the Target Product Profile.
- Manage interactions with Health Authorities for assigned project(s) to ensure acceptance, rapid review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
- Maintains an in-depth level of understanding of the company's compounds, their characteristics, manufacturing aspects and specifications/analytical methods.
- Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected.
- Coordinate preparation and review technical reports and CMC sections of global submissions to support clinical investigation and marketing applications.
- Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships with CRO's or others who work on the company's behalf.
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
- Support CMC QA functions, e.g deviations, general GMP/regulatory mixed topics.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
- Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise project teams accordingly.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS: - Accredited bachelor's degree.
- Minimum of eight (8) years of experience in the Pharmaceutical, Biotech or Medical Device Industry with direct experience with small molecule/biologic technical functions.
- Minimum of five (5) years of experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing.
- Capability to interact with CMC technical experts regarding process development and analytical issues.
- Demonstrated success in global submission filing, approval, and lifecycle management.
- Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS: - Bachelor of Science or Arts Degree; life science related degree.
- Master or PhD of Science.
- Combination product (drug/device) experience.
TRAVEL:- Willingness/Ability to travel up to 10 % international travel will be required.
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $220,000 - $250,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1
