Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

Syneos Health/ inVentiv Health Commercial LLC; Massachusetts; On-site; USD 56,000 - 115,000; Full time

Benefits offered by this job

Company car or car allowance

Medical, Dental and Vision benefits

401k matching

Employee Stock Purchase Plan

Bonuses/Commissions

Paid time off

Job summary

Syneos Health is a leading life sciences services company seeking a regulatory affairs specialist focused on CMC to manage lifecycle submissions across US/CA/EU. The role involves regulatory strategy and cross-functional teamwork.

You will review CMC sections, interact with agencies, and collaborate with global teams to shape compliant submissions for assigned products. A bachelor’s degree in life sciences and about four years of pharma experience are preferred.

Qualifications

• Bachelor's degree in life sciences or related field.
• Typically 4 years of pharmaceutical industry experience or equivalent.
• Experience supporting Small Molecule programs preferred.

Responsibilities

• Execute commercial Lifecycle Management strategy and submissions focused on US/CA/EU.
• Review CMC sections of regulatory submissions and agency interactions.
• Develop global regulatory CMC strategies in collaboration with Regulatory.
• Serve as primary regulatory CMC contact for assigned products/projects.

Skills

Strong interpersonal skills

Regulatory guidelines proficiency

Problem-solving skills

Collaboration and communication

Planning and prioritization

cGMP knowledge

Education

Bachelor's degree in life sciences

Job description

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.