About the Role:Responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.
Your Contributions (include, but are not limited to):- Responsible for contributing to the regulatory CMC strategy and execution for assigned commercial and development projects, including responsibility for significant contributions to IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects
- Develops CMC regulatory plans to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities
- Provides expertise on global regulatory CMC requirements to management and project teams
- Provides expert advice to product development team within CMC areas on all regulatory issues for the development, planning, compilation and submission of IND/CTA/MAA/NDA/BLA
- Leads interactions and negotiations with regulatory agencies during all stages of development and registration
- May lead preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA).
- Creates, reviews and edits reports and regulatory submissions
- Actively engages with stakeholder groups to help shape science based regulatory decision making
- May act as regulatory CMC liaison with partner companies and contract manufacturers
- Other duties as assigned
Requirements:- BS/BA degree in Life/Health Sciences or related field AND 8+ years of Regulatory Affairs experience in a pharmaceutical company with focus on CMC activities. Experience managing external contract services, and direct interaction with FDA. OR
- Master's degree in Life/Health Sciences or related field AND 6+ years of similar experience noted above OR
- PhD AND 4+ years of similar experience noted above
- Demonstrates broad expertise or unique knowledge
- Considered an expert within the company and may have external presence in area of expertise
- Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
- Ability to work as part of and lead multiple teams
- Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills.
- Sees broader picture and longer-term impact on division/company.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Excellent project management, strong project leadership skills
- Anticipates business and industry issues; recommends relevant process / technical / service improvements
- Strong knowledge of FDA regulations, including current Good Manufacturing Practices
- Proven experience with electronic filing (eCTD), electronic document management systems and with document review and approval processes
- Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals
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The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
