Sr. Manager, Chemistry, Manufacturing and Controls (CMC)
Romark
Tampa, FL 33607
Remote
Job details
Job Type
Full-time
Number of hires for this role
1
Qualifications
• • Bachelor's (Preferred)
Full Job Description Summary/Objective
This key role will provide input to Chemistry, Manufacturing, and Controls (CMC) strategies, and operational CMC regulatory support for development and commercialization of products. Responsible for development of the CMC regulatory strategy, coordinating timely preparation and maintenance of CMC sections to support investigational (INDs), marketing applications (NDAs), and Drug Master Files (DMFs) and international filings as necessary. Will have a direct role in implementing regulatory CMC policy throughout the drug development process.
Essential Functions
• Works closely with other members of the Regulatory Affairs team, R&D, Quality, and manufacturing teams to plan activities in support of product development and upcoming CMC regulatory submissions.
• Provides key input to the development of the US and global CMC regulatory strategy and serves as CMC advisor on regulatory issues relating to both developmental and marketed products to allow timely completion of development plans.
• Manages the preparation and content of CMC sections to support US and international regulatory submissions (such as INDs, CTA’s, NDAs, DMFs, international marketing applications, etc.)
• Develops the regulatory strategy for CMC post-approval changes and prepares and/or oversees the preparation of CMC supplemental applications and CMC sections of annual reports.
• Critically reviews CMC regulatory submissions and supporting documentation to ensure accuracy, adequacy and conformance to regulatory requirements. Writes, edits, and/or oversees the preparation of CMC submission documentation, as necessary.
• Coordinates and provides timely responses to CMC questions from Regulatory agencies.
• Coordinates preparation of information and related activities for CMC meetings with health authorities
• Reviews and assesses Change Control documentation for regulatory impact and GMP compliance
• Review CMC aspects of drug labeling.
• Represents Regulatory Affairs-CMC on cross-functional teams and committees as appropriate.
• Maintain effective relationships with CMC functional areas and external partners.
• Serve as a direct point of contact with health authorities for CMC issues
• Works with Regulatory Operations to plan and manage electronic CTD dossiers for optimal efficiency over product lifecycle.
• Maintains current, in-depth knowledge of CMC regulatory requirements
• Supervises and mentors junior members of the Regulatory Affairs Department assisting in the preparation of submissions with CMC content.
Contribute to preparation of group/departmental or company operating policies and procedures.
Qualifications
Education and/or Experience
Degree in chemistry or other scientific discipline
• 8 years or more in the pharmaceutical industry with a minimum of 5 years in CMC Regulatory Affairs or equivalent experience working with the CMC CTD Module.
• Experience in product development, quality control/quality assurance for pharmaceutical products with a strong understanding of GMPs
• Experience in preparing & reviewing CMC investigational, marketing, and post-marketing regulatory submissions.
• Understanding of product development and regulations for solid oral dosage forms a plus.
• Experience with submitting and maintaining CMC submissions in CTD format
• Ability to establish and maintain effective working relationships
• Detail-oriented, with good organizational and project management skills
• Strong analytical and interpretive skills
• Demonstrated interpersonal, verbal and written communication skills; Ability to build relationship with clients and co-workers.
• Strong working knowledge of FDA and ICH guidelines and their application to the CMC portions of regulatory submissions.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Ability to read, analyze, and interpret scientific, technical data, and regulatory guidelines and regulations.
• Excellent analytical and problem solving skills; scientific and/or technical knowledge pertaining to pharmaceutical development or operations.
• Ability to work in a fast paced environment with changing priorities
• Detail-oriented, with good organizational and project management skills
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Demonstrated ability to deal with confidential information.
• Ability to work as part of a team and independently; displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgement.
• Strong integrity and work ethic are critical.
• Able to anticipate problems.
Job Type: Full-time
Pay: $0.00 per year
Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Relocation assistance
• Retirement plan
• Vision insurance
Schedule:
• Monday to Friday
Supplemental Pay:
• Bonus pay
Education:
• Bachelor's (Preferred)
Work Location:
• One location
Company's website:
• www.Romark.com
Benefit Conditions:
• Only full-time employees eligible
Work Remotely:
• Yes
COVID-19 Precaution(s):
• Remote interview process
• Social distancing guidelines in place
• Virtual meetings
• Sanitizing, disinfecting, or cleaning procedures in place