Senior Manager, Regulatory Operations

POSITION SUMMARY:

As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Senior Manager, Regulatory Operations. The Senior Manager, Regulatory Operations is responsible for the daily operational activities for global regulatory submissions and archives in accordance with agency requirements and company standards. Provide system administration support of the Electronic Document Management System (EDMS).

JOB RESPONSIBILITIES:

• Manage and performs daily operational activities for global regulatory submissions (project management, resource scheduling, formatting, publishing, QC, archive and submission)
• Collaborates with interdisciplinary teams, international colleagues, vendors and Regulatory Affairs in the management of submission components and tracking of deliverables
• Ensure consistency, completeness, and adherence to agency guidelines, internal work instructions and SOPs
• Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines
• Evaluate, author and review SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations
• Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
• Stay current with new electronic submission and regulatory documentation practices issued from global health authorities
• Author, review and maintain training materials for Regulatory systems
• Provide companywide individual and group training on EDMS
• Review, test, and implement new software releases and upgrades for Regulatory owned systems
• Assumes other relevant assignments as directed by the Head of Regulatory Operations
• Maintain tracking documents as well as publishing and submission calendars

QUALIFICATIONS:

• Bachelor’s degree with 8 years of experience in the pharmaceutical industry, 6+ years in regulatory operations, preferred; or equivalent combination of education and industry experience.
• Experience with electronic submission building tools, document formatting and publishing standards
• Experience using electronic document management system (EDMS)

REQUIRED KNOWLEDGE AND ABILITIES:

• Experience with electronic submissions, advanced PDF publishing tools, creating/maintaining templates, and management of EDMS
• Requires knowledge of applicable Regulatory Agency regulations, guidelines, and specification (FDA, HC, EMA, ICH, etc)
• Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat and the use of PDF Processing Tools (ToolBox), eCTD validation and viewers
• Works independently, is able to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure
• Ability to independently problem solve and offer solutions to functional leaders and collaborators.
• Knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
• Strong verbal and written communications skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
• Consistent demonstration and embodiment of our Corporate Beliefs: Passion for Innovation; Think Big, Act Small; Learn to Dare; and Teams Build the Future
• Ability to have fun and thrive in a growing, diverse, and inclusive work environment

ABOUT INTERCEPT:

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). In a new age of liver disease treatment, our team is developing vital therapies to meet the needs of those living with rare and serious liver disease. We are committed to improving patients’ lives and addressing the liver community’s most pressing needs.

People at Intercept are passionate about patients. You’ll see our patient photos lining our walls and hear their stories in town halls.  We’re equally passionate about our team, ensuring each member feels included and has the opportunity to reach their potential.  We recognize the power of an equal opportunity work force, and how it enriches the professional lives of our team members. Equal opportunity drives innovation and connects us to the patients and communities we serve.

For more information about Intercept, please visit our website at: www.interceptpharma.com and follow us on X at: @InterceptPharma.

COMPENSATION & BENEFITS:

The anticipated salary range for this position is $140,000 to $180,000. This represents the anticipated low and high end of the salary range for this position.  Actual salaries may vary based on various factors including, but not limited to, experience, skillset, and performance.  

The salary range listed is just one component of our total compensation package.  Intercept also provides a competitive suite of benefits, including:

• 401(k) plan with company match
• Rewards and recognition program
• Health care benefits (medical, prescription drugs, dental, and vision insurance)
• Short and long-term disability coverage provided
• Plan coverage for domestic partners
• Paid parental leave benefits and adoption assistance
• Tuition reimbursement assistance
• A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year
• Numerous well-being and work/life programs

EEO Statement

Employment decisions at the Company are made without unlawful regard to race, color, religion, creed, national origin, alienage or citizenship status, sex (including gender, pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, sexual orientation, national origin, ethnicity, age, physical or mental disability, legally protected genetic information, marital or partnership status, sexual and reproductive health decisions, military or veteran status, or any other status protected by applicable federal, state, or local law. This organization participates in E-Verify (E-Verify's Right to Work guidance can be found here:  https://www.e-verify.gov/sites/default/files/everify/posters/IER_RighttoWorkPoster.pdf).

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