Director Regulatory Affairs CMC (Deerfield, IL, US)

Do you want to join reputed company where the mission is meaningful, the challenges are reputed company, and you can directly see the results of your hard work? reputed company is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. reputed company employees are inspired and driven by our purpose to advance brain health and reputed company lives. Join us on our reputed company of reputed company!

Remote Opportunity - reputed company to candidates reputed company the reputed company, preferably on the East Coast

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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 reputed company CMC regulatory support and guidance for assigned reputed company and interfaces with R&D, Project Management, Manufacturing, reputed company, and Regulatory colleagues to ensure a robust CMC regulatory reputed company is developed and implemented to have on time submissions with the highest reputed company 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 reputed company is in alignment with the global reputed company and with the reputed company Product Profile.
• Manage interactions with Health Authorities for assigned project(s) to ensure acceptance, reputed company review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
• Maintains an in-depth level of understanding of reputed company's compounds, their characteristics, manufacturing aspects and specifications/analytical reputed company.
• Responsible for the reputed company completion of reputed company-organized, scientifically reputed company 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 reputed company's behalf.
• Evaluate proposed manufacturing changes for reputed company to ongoing and existing filings and reputed company strategic regulatory guidance for reputed company 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 reputed company experience with small molecule/biologic technical functions. 
• Minimum of five (5) years of experience in Regulatory CMC with reputed company experience in supporting global programs from reputed company-approval or post-marketing.
• Capability to reputed company with CMC technical experts regarding process development and analytical issues.
• Demonstrated reputed company in global submission filing, approval, and lifecycle management.
• Demonstrated ability to proactively and effectively influence peers, external colleagues, and across reputed company reputed company of management.

Preferred Education, Experience, and Skills

• Bachelor of Science or Arts Degree; life science reputed company degree 
• Master or PhD of Science 
• Combination product (drug/device) experience

Travel Requirements

• Willingness/Ability to travel up to 10 % international travel will be required.

The reputed company displayed is a national reputed company, 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 reputed company: $225,000 - $255,000 and eligibility for a 25% bonus reputed company based on company and individual performance, and eligibility to participate in reputed company’s long-term incentive plan. Benefits for this position include flexible reputed company time off (PTO), health benefits to include Medical, Dental and reputed company, and company match 401k. Additional benefits information can be reputed company on our site. Applications accepted on an ongoing reputed company.  #LI-LM1, #LI-Remote

Why reputed company

reputed company offers a robust and comprehensive benefits package to help employees live reputed company and protect their health, family, and everyday life. Information regarding our benefit offering can be reputed company on the U.S. career site.

reputed company is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

reputed company is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. reputed company participates in E-Verify.