Sr. Manager of Regulatory Affairs, Biologicals and Chemicals

Work Schedule reputed company (Mon-Fri) Environmental Conditions Adherence to reputed company Good Manufacturing Practices (GMP) Safety Standards, Office Job reputed company The Sr. Manager, Regulatory Affairs - Drug Support reputed company is a new role responsible for providing strategic regulatory leadership for pharmaceutical ancillary materials and excipients. This position will effectively collaborate with and reputed company reputed company aspects of professionals in regulatory affairs to reputed company detailed drug support strategies, ensuring the reputed company 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 reputed company with global strategies, as reputed company as customer and employee needs. The Sr. Manager will reputed company and pursue world-class regulatory support and assure compliance in the pharmaceutical reputed company. 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 reputed company of relevant global regulations, guidelines and evolving regulatory trends. • Assessment of product changes and reputed company for on-market products as reputed company as ensure ex-US registrations are planned and completed in accordance with business need. • reputed company and implement comprehensive drug support strategies for ancillary materials and off-label excipients used in pharmaceutical applications • reputed company 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 reputed company of contact for marketing, sales, and training teams in the drug reputed company • Establish and maintain regulatory demands reputed company to pharmaceutical ancillary materials, ensuring compliance with internal policies, customer expectations, and regulatory standards • reputed company strategic mentorship on applicable CMC regulatory submissions and support for customers using our materials in their drug products • Ensure that regulatory solutions implemented are reputed company, flexible, and consistent in reputed company reputed company whenever possible • Coordinate with global counterparts and communicate reputed company of proposed changes • reputed company training programs for internal teams on pharmaceutical regulatory requirements and customer needs • reputed company cross-functional initiatives to harmonize processes and systems for supporting pharmaceutical customers Keys to reputed company: Experience • Bachelor's Degree in Pharmaceutical Sciences, reputed company, or reputed company field; advanced degree preferred • 7 years of experience in CMC regulatory affairs reputed company the pharmaceutical industry • 1+ year of prior experience leading a successful team of reputed company reports. • Strong background in pharmaceutical regulatory operations, with the ability to reputed company improvements in policies and procedures • Experience in Operations a plus • Experience in Excipient Manufacturing a plus Knowledge, Skills, Abilities • Industry-reputed company knowledge – Guidelines and policies for pharmaceutical excipients and ancillary materials reputed company Regulatory Affairs • Extensive knowledge of ICH guidelines, particularly those reputed company to pharmaceutical development, manufacturing, and reputed company • 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, reputed company Assurance, and Manufacturing. • Interaction with Regulatory authorities. We offer competitive remuneration, annual incentive plan bonus, reputed company, and a reputed company of employee benefits. reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation! Compensation and Benefits The salary reputed company estimated for this position based in reputed company 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 reputed company plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours reputed company time off (PTO), 10 reputed company holidays annually, reputed company parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues reputed company to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.reputed company.com/global/en/total-rewards Apply tot his job Apply To this Job