CMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL)

SciLucent, Inc., an employee-owned (ESOP) Northern Virginia-based scientific consulting firm providing innovative solutions in all aspects of drug development. We are committed to helping our clients navigate the complexities of the pharmaceutical industry to achieve their goals. Our scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants. We are looking for an enthusiastic, adaptable, self-motivated individual with excellent English communication skills.

Responsibilities of the position include:

• Develop and provide strategic CMC regulatory guidance to clients including planning, authoring, and managing the production of clear and persuasive CMC-related regulatory submissions for pharmaceuticals, biologics, and combination products such as INDs, NDAs/BLAs, meeting requests, and meeting packages.
• Support regulatory agency interactions, including preparation for meetings and responding to information requests.
• Develop, manage, and ensure that overall project timelines support the coordination and preparation of timely submissions.
• Communicate and coordinate with relevant internal and external clients and team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions.
• Act as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
• Maintain up-to-date working knowledge of relevant regulatory regulations, guidance, and the current regulatory environment.
• Provide mentorship to internal team members through sharing of information on regulatory CMC issues.

Qualifications

Required

• Master's degree or equivalent experience in a scientific field (e.g., biology, chemistry, biochemistry, etc.).
• A minimum of 10 years in the pharmaceutical/biotechnology industry and/or consulting with at least 8 years in CMC Regulatory Affairs.
• Strong understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Experience with CTD format and content.
• Ability to work independently and within a group setting and to interact effectively with different functional areas, exercise sound judgment, and take ownership of deliverables.
• Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Excellent ability to critically analyze and interpret scientific data, interact with scientific professionals
• Excellent understanding of complex to highly complex product development, the product industry, and regulation
• Strong ability to identify, develop, grow the client base and build and cultivate repeat, long-term relationships
• Strong business acumen
• Strong computer skills using MS Word, Excel, PowerPoint.

Preferred

• Prior regulatory consulting or client‑facing experience.
• Experience with small molecules and/or biologics.
• Familiarity with accelerated development pathways and global regulatory strategies.

Employees work remote from their home office which must be located in the United States. Our most valuable resource is our people . We hire intelligent, creative, passionate professionals with an ardent desire to learn. At our core is collaboration, camaraderie, growth, and collective hard work, without egos. Our culture is one that encourages, supports, and celebrates our colleagues! We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development. Additionally, we offer the following benefits: medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO. The annual base salary for this position ranges from $115,000 - $215,000 depending on qualifications and experience. Any salary offered is based on internal equity, internal salary ranges, market data/ranges, applicant's skills and prior relevant experience, certain degrees, and certifications.

Please send a resume and cover letter to [email protected]. Applications without cover letters will not be reviewed.

SciLucent is an equal opportunity employer. We thank all applicants for their efforts in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.