Sr. Manager of Regulatory Affairs, Biologicals and Chemicals

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

The Sr. Manager, Regulatory Affairs - Drug Support Strategy is a new role responsible for providing strategic regulatory leadership for pharmaceutical ancillary materials and excipients. This position will effectively collaborate with and lead all aspects of professionals in regulatory affairs to develop detailed drug support strategies, ensuring the safe and compliant handling of ancillary materials used in pharmaceutical applications.

This Regulatory leader will work closely with cross-functional teams to execute company priorities and partner with the Leadership Team to drive initiatives that are closely aligned with global strategies, as well as customer and employee needs. The Sr. Manager will develop and pursue world-class regulatory support and assure compliance in the pharmaceutical space.

Location:

This is a remote position available for hire in the USA or Scotland. Residency in the US or Scotland required. No relocation assistance will be provided.

Job Responsibilities

A day in the Life:

• Interpret and communicate impact of relevant global regulations, guidelines and evolving regulatory trends.
• Assessment of product changes and impact for on-market products as well as ensure ex-US registrations are planned and completed in accordance with business need.
• Develop and implement comprehensive drug support strategies for ancillary materials and off-label excipients used in pharmaceutical applications
• Lead regulatory affairs talent passionate about supporting customer drug filings and CMC documentation
• Support customer due diligence processes and handle regulatory documentation requests
• Serve as the special point of contact for marketing, sales, and training teams in the drug space
• Establish and maintain regulatory demands related to pharmaceutical ancillary materials, ensuring compliance with internal policies, customer expectations, and regulatory standards
• Provide strategic mentorship on applicable CMC regulatory submissions and support for customers using our materials in their drug products
• Ensure that regulatory solutions implemented are scalable, flexible, and consistent in all regions whenever possible
• Coordinate with global counterparts and communicate global impact of proposed changes
• Develop training programs for internal teams on pharmaceutical regulatory requirements and customer needs
• Lead cross-functional initiatives to harmonize processes and systems for supporting pharmaceutical customers

Keys to Success:

Experience

• Bachelor's Degree in Pharmaceutical Sciences, Chemistry, or related field; advanced degree preferred
• 7 years of experience in CMC regulatory affairs within the pharmaceutical industry
• 1+ year of prior experience leading a successful team of direct reports.
• Strong background in pharmaceutical regulatory operations, with the ability to lead improvements in policies and procedures
• Experience in Operations a plus
• Experience in Excipient Manufacturing a plus

Knowledge, Skills, Abilities

• Industry-related knowledge – Guidelines and policies for pharmaceutical excipients and ancillary materials within Regulatory Affairs
• Extensive knowledge of ICH guidelines, particularly those related to pharmaceutical development, manufacturing, and quality
• Understanding of business processes – Regulatory Affairs systems

Physical Requirements / Work Environment

• Regular interaction with cross-functional teams, such as Research and Development, Product Management, Marketing, Quality Assurance, and Manufacturing.
• Interaction with Regulatory authorities.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in New York is $118,000.00–$157,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national