The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. These activities include acting as a regulatory CMC representative on cross-functions teams, planning regulatory CMC submission strategies, and conducting regulatory CMC intelligence activities.
Key Responsibilities- Independently develops and leads execution of regulatory CMC strategies for products in the investigational, registration and/or post-approval lifecycle.
- Applies expert regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Guides the team in defining and driving the strategy for CMC regulatory dossier content and then writes and/or reviews this content for conformance with established Health Authority requirements.
- Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related topics.
- Provides global regulatory input and support to quality-related activities, including inspections and regulatory impact assessments for change controls, deviations and investigations.
- Proactively identifies regulatory CMC risks and develops mitigation strategies, ensuring timely communication with line management.
- Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and emerging trends.
Required & Desired Qualifications- BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
- Minimum 15 years' regulatory CMC experience, along with broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life cycle management of small molecule products is required.
- Demonstrated experience interacting with global Health Authorities on CMC topics.
- Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals is required.
- Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with technical SMEs at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies
- Hybrid opportunity (3 days per week in office required) based in our Waltham, MA or Conshohocken, PA offices.
Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $258,827- $293,479 per year. We comply with all applicable minimum wage laws.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [redacted].
Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.
Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [redacted].
