Director, Regulatory CMC

Apex Systems; Boston (MA); Remote; USD 160,000 - 200,000; Full time

Job summary

A leading company is seeking a Director of Regulatory CMC to develop and lead CMC regulatory strategies, manage submissions, and ensure compliance with health authorities. The ideal candidate will have extensive experience in the biopharma sector with a robust understanding of regulatory affairs.

Benefits

Comprehensive benefits package

401K program with company match

Employee stock purchase program

Access to on-demand training programs

Health Savings Account

Qualifications

• 10+ years in CMC Regulatory Affairs
• Experience in securing market application approvals
• Global post-approval product life-cycle management experience

Responsibilities

• Develop CMC regulatory strategies and manage submissions
• Lead discussions with global health authorities
• Collaborate with teams on compliance requirements

Skills

Leadership

Communication

Regulatory Strategy

Education

Bachelors in Science

Job description

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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

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