Description
Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have
Job Responsibilities
Key Duties and Responsibilities
• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Required Education Level & Experience
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience
• Preferred experience supporting Small Molecule programs
Required Knowledge/Skills
• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
• Strong problem-solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Sound knowledge of cGMP, FDA, EMA, ICH
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$56,400.00 - $115,100.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
Summary
General Position Summary The Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.
