Associate Director, CMC Regulatory Affairs

$135,000 - $232,300/Yr

Johnson & Johnson - Montpelier, VT

Full-time - Mid Level

Remote - Montpelier, VT

Chemical Manufacturing

About the position

The Associate Director, CMC Regulatory Affairs at Johnson & Johnson is responsible for guiding the CMC and regulatory aspects of pharmaceutical development and commercialization, particularly for parenteral products. This role involves developing global CMC regulatory strategies, providing regulatory expertise, and ensuring compliance with local regulatory requirements throughout the product lifecycle. The position requires collaboration with cross-functional teams and health authorities to facilitate successful product development and regulatory submissions.

Responsibilities

• Provides guidance and expertise to the Global Regulatory Team to develop global submission plans that comply with local regulatory requirements and commitments.
• Develops and executes CMC regulatory strategies that support the development of the products in which the candidate is responsible for.
• Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development globally.
• Leads the preparation of regulatory dossiers for submission to Health Authorities.
• Provides technical expertise and technical input in the preparation and writing (as applicable) of regulatory dossiers for submission to Health Authorities globally.
• Has experience with writing/ reviewing briefing books & responding to questions from the Health Authorities.
• Has participated in Health Authority meetings and has experience in drafting questions and company position for the Health Authorities.
• Assesses manufacturing changes and evaluates the impact on marketing applications.
• Works closely with supply chain to ensure continuity of product.
• May lead selected initiatives within the department.
• Participates in and conducts due diligence/licensing evaluations as needed.
• Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.

Requirements

• Minimum of Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required.
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry, parenteral experience preferred.
• Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.
• Strong attention to detail with high-level verbal and written communication skills.
• Strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.

Nice-to-haves

• An MS, Ph.D., or Pharm. D. degree preferred.
• Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.
• Good understanding of competitors in the area and what they are doing in early/late development.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and savings plan (401(k)).
• Long-term incentive program.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year.