Executive Director, Chemistry, Manufacturing & Controls (Cmc) Pre-Approval Pharm
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Executive Director, Chemistry, Manufacturing & Controls (Cmc) Pre-Approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our company. They will lead a team of Cmc professionals, ensuring rigorous Cmc regulatory strategy and delivery of high-quality submissions for products that may include respiratory / inhalation, peptide, antibody-drug conjugates (ADCs), and traditional solid-oral small molecules.
The Executive Director will help drive our company's growth into new modalities and innovative approaches with FDA and other regulatory authorities. This role will also be a lead and advocate for digital innovation and leveraging it for how we operationalize Cmc. This individual will be a senior member of the Regulatory Affairs Cmc organization and will also manage significant cross-modality projects as an extension of the overall Regulatory Affairs Cmc Leadership Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs Cmc (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global Human Health (GHH) divisions to ensure these programs are compliant and available to patients in markets as needed.
Primary Responsibilities :
Education :
Required Experience and Skills :
Required Skills :
Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biochemistry, Cross-Cultural Awareness, Customer Problem Solving, Documentation Standards, Document Control Systems, Driving Continuous Improvement, Electronic Common Technical Document (eCTD), Executive Business Management, Immunochemistry, Influence, Innovation, Interpersonal Relationships, Manufacturing Compliance, Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, Regulatory Requirements, Regulatory Strategy Development, Research Development, Risk Analysis {+ 1 more}
Preferred Skills :
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit :
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We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills, and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is $227,300.00 - $357,900.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(
Director Regulatory Cmc • Rahway, NJ, US