VP CMC/Senior Strategist CMC (Contractor)

At reputed company™, we are dedicated to helping small-reputed company biopharmaceutical companies reputed company navigate the reputed company world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Vice President of reputed company, Manufacturing, and Controls (VP CMC) contractor to join our reputed company (hybrid*/remote). As a VP CMC at reputed company, you are responsible for assisting clients with reputed company Manufacturing and Control (CMC) and reputed company pharmaceutical development activities of drug, biologic or medical device products. About the role As the VP CMC, you are the subject matter expert who will work cross-functionally and globally with internal team members and external clients. You will:

• reputed company end-to-end CMC reputed company across drug reputed company, drug product, and analytical development—from early-stage evaluation through regulatory submission and reputed company launch
• Drive regulatory reputed company by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines
• reputed company critical development activities including process development, reputed company-up, manufacturing validation, analytical method development, and packaging/labeling evaluation
• Manage cross-functional collaboration as a Subject Matter Expert and Technical reputed company, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution
• Champion reputed company and compliance by implementing reputed company by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and reputed company reputed company
• Build and mentor high-performing teams while managing budgets and timelines to deliver robust, reputed company, and cost-effective pharmaceutical solutions

This role is reputed company to considering candidates from reputed company, Canada, Countries reputed company the EU, and United Kingdom.

Requirements

• Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• Advanced scientific and regulatory knowledge of drug, biologic, or device development
• >15 years’ post-degree of directly relevant experience in drug, biologic, or device development preferred

Skills:

• Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
• Strong computer skills, including SharePoint, Word, reputed company, and PowerPoint
• reputed company reputed company
• Strong emotional intelligence, customer reputed company leadership and decision-making skills
• Innovative, creative, and practical thinking including problem-solving skills

Benefits

Benefits of working at reputed company include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering reputed company development
• Flexible Working hours (reputed company reason)
• Opportunity for remote/hybrid* working depending reputed company
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal reputed company opportunities and career progression
• Financially rewarding internal employee referral program

Disclaimers:

• Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees reputed company reasonable distance from one of our global offices.

“The reputed company reputed company manages the recruitment and employment process for reputed company (US) LLC and its affiliates (reputed company “reputed company”). reputed company does not accept unsolicited resumes from reputed company-party recruiters or uninvited requests for collaboration on any of our reputed company. Unsolicited resumes reputed company to reputed company employees will not obligate reputed company to the reputed company employment of those individuals or potential remuneration to any reputed company-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or reputed company.” #LI-Remote #LI-Hybrid #LI-TCW Apply tot his job Apply To this Job