Remote/Commuter Opportunity - Open to candidates within the United StatesThe Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to ensure the successful development and approval of assigned drug and biological products for the United States (global products as well as US only products). Provides direct oversight and coordination for US based strategists. Directs a cross functional team to ensure that regional requirements and expectations are achieved in an optimal and compliant manner.
ESSENTIAL FUNCTIONS: - Serves as US and/or global product registration leader for US products, influencing cross functional development teams and governance.
- Oversees assembly and creation of documentation to support investigational and marketing registration packages for the US FDA.
- Liaises with FDA as needed for all aspects pertaining to drug development, approval, and post-approval activities.
- Provides high-level RA advice and identifies regulatory requirements for clinical studies and marketing approval in US.
- Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings.
- Assesses scientific data for registration purposed against regulatory requirements.
- Maintains awareness of global regulatory legislation and assess its impact on business and Lundbeck product development programs.
- Trains, develops, and manages an effective regulatory affairs cross-functional team on a dotted-line basis (CMC, Regulatory Operations, US Labeling, Promotion Compliance & Scientific Messaging, and International regulatory).
REQUIRED EDUCATION, EXPERIENCE AND SKILLS: - Accredited bachelor's degree.
- 10+ years R&D experience within a pharmaceutical and/or biotech industry, with 7+ years' experience in Regulatory Affairs.
- Experience with supporting both small molecule and biological products and ensuring regulatory compliance.
- Regulatory management experience (direct or indirect)
- Demonstrated and successful experience with face to face, hybrid, and/or virtual FDA interactions.
- Ability to lead and work in cross-functional, matrixed, hybrid and multinational teams.
- Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies.
- Demonstrated record of investigational and marketing application compliant management and approvals.
- Proven ability to navigate complex compliance and regulatory strategies.
- Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective.
- Provider of contingencies and alternate approaches to cross functional leadership and alliances.
- Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems.
- Ability to influence regulatory agency management at all levels to support regulatory needs.
- Highly proficient in communicating strategic and tactical issues to cross functional management.
- Effectively able to multi-task within assigned deadlines.
- Excellent written and oral communication skills.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS: - Accredited Bachelor's Degree in life sciences.
- Masters. Doctorate Degree or MBA, other professional certifications.
- FDA experience.
- Exposure to international regulatory affairs, including participation in submissions to ex-US authorities.
- Strong Preference to be based in Deerfield, IL Office.
TRAVEL: - Willingness/Ability to travel up to 20% domestically, and international travel may be required.
- If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business.
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: $200,000 - $235,000 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 career site. Applications accepted on an ongoing basis. #LI-LM1
