Senior Director, Regulatory Strategy

Director, Regulatory CMC page is loaded## Director, Regulatory CMClocations: PA - Conshohocken - Officetime type: Full timeposted on: Posted Todayjob requisition id: JR\_000607Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.Management of regulatory activities for all projects assigned by the head Regulatory CMC. Ensure regulatory conformance for commercial products through effective change management. Maintain a high level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy. Provide regulatory strategy for life-cycle management. Provide regulatory support for due diligence activities associated with the assessment of business opportunities.**Responsibilities**Management of all regulatory activities for development and commercial projects assigned by the Head of Regulatory CMC:* Act or assign a regulatory representative for each assigned project team.* Oversee the development and implementation of regulatory submission strategy.* Manage the planning, preparation and technical review of regulatory submissions and ensure submissions are completed to meet required/established timelines.* Collaborate on the development and/or optimization of product development strategy to be consistent with regulatory requirements.* Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions.* Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.* Provide regulatory guidance and strategy for life-cycle management planning and development for assigned commercial products.* Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes.* Ensure regulatory conformance for commercial products through effective change management.* Provide regulatory support for due diligence activities associated with the assessment of business opportunities.**Qualifications*** Graduate degree in a scientific/technical discipline (Ph.D., MS Science or PharmD.) with a minimum 12 years pharmaceutical drug development experience and 7 years hands-on regulatory experience.* Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.* Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals.* Basic computer skills (MS Office, Excel and Adobe Acrobat).* Strong knowledge of regulations/guidelines governing pharmaceutical/biologics development is required.* Familiarity/understanding of FDA regulatory processes (experience with ex-US regulatory authorities/processes is required).* Ability to communicate clearly and concisely with senior management and regulatory authorities.* Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.\*requires occasional business travelExperience supporting and conducting due diligence activities.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 $208,000 - $254,000 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 View email address on click.appcast.io. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our 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 #J-18808-Ljbffr