Director, Regulatory CMC Job at Apex Systems, Boston, MA

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  • Apex Systems
  • Boston, MA

Job Description

Join to apply for the Director, Regulatory CMC role at Apex Systems 1 week ago Be among the first 25 applicants Join to apply for the Director, Regulatory CMC role at Apex Systems Get AI-powered advice on this job and more exclusive features. Job#: 2070371 Job Description: Director, Regulatory CMC 2070371 Location: Boston, MA (Remote) Focus: Rare disease/biologics Job Overview: Reporting to the Head of Regulatory Affairs CMC, the Director will lead CMC regulatory strategies, align global requirements with development plans, and manage submissions and interactions with Health Authorities, driving team and corporate objectives. Primary Job Responsibilities: Develop CMC regulatory strategies, pinpointing critical issues and acceleration opportunities. Serve as the regulatory point of contact in internal and cross-functional CMC meetings. Guide project teams on global CMC regulatory strategies and compliance requirements. Initiate and lead proactive discussions with global health authorities. Organize and engage in CMC regulatory interactions with agencies like FDA and EMA. Assist in GMP inspections and manage comprehensive regulatory submissions. Collaborate with external contractors to maintain and update regulatory plans. Oversee CMC regulatory project reviews, budget management, and routine updates. Keep informed on new CMC regulatory policies and manage resolution of regulatory issues. Primary Job Requirements: Bachelors in science with 10+ years in CMC Regulatory Affairs with escalating responsibility within the biopharma sector. Experience in securing approvals for market applications is mandatory. Must possess global post-approval product life-cycle management experience. Proven track record in strategic drug development and commercial support. Demonstrated success in global regulatory affairs, including drug registrations in US, EU, and beyond. Strong leadership with adept communication skills for influential regulatory strategy guidance. Independent work ethic, commendable teamwork, and excellent oral/written communication proficiency. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide. Apex Systems is part of the Commercial Segment of ASGN Incorporated.

NYSE: ASGN

4400 Cox Road Suite 200 Glen Allen, Virginia 23060 Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Legal Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Apex Systems by 2x Sign in to set job alerts for “Legal Director” roles. Boston, MA $160,000.00-$200,000.00 3 weeks ago Chief of Staff, Betsy Lehman Center for Patient Safety Boston, MA $125,000.00-$150,000.00 2 hours ago Cambridge, MA $236,600.00-$439,400.00 14 hours ago Director/Senior Director, Corporate Counsel SVP, Associate General Counsel, Chief Privacy Officer Boston, MA $207,075.00-$345,125.00 19 hours ago Waltham, MA $177,000.00-$336,000.00 6 days ago Associate General Counsel, Corporate and Commercial Operations Director, Global Regulatory Lead, GI & Inflammation Associate Director - Global Regulatory Lead, GI & Inflammation Chief Privacy Officer & Senior Legal Director Marlborough, MA $164,800.00-$313,200.00 1 week ago Director of Privacy & Senior Legal Counsel Boston, MA $85,000.00-$125,000.00 1 month ago Cambridge, MA $204,400.00-$379,600.00 1 week ago Director, Practice Operations - Litigation Associate Director, Global Compliance & Ethical Sourcing SVP, Associate General Counsel – Business and Institution Support Boston, MA $207,075.00-$345,125.00 3 days ago ProFound Therapeutics: Senior Director, IP Counsel Vice President Legal Counsel - US Institutional Product Team In-House Corporate Counsel - Investment Banking New York City Metropolitan Area 2 days ago Director, Assistant General Counsel – Securities Associate Director or Director, Compliance Counsel Boston, MA $180,100.00-$293,638.00 2 weeks ago Associate Director/Director, Global Regulatory Lead Associate Director/Director, Intellectual Property (Patent Counsel) Senior Director, Senior Corporate Counsel We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Apex Systems

Job Tags

Full time, For contractors, Remote job,

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