CTG Associate Director of Regulatory Affairs in Cambridge, Massachusetts
Title: Associate Director of Regulatory Affairs
Job Number: 18208396
CTG's premier client in Cambridge, MA, has an assignment for an Associate Director of Regulatory Affairs.
Major responsibilities of this position are:
Work proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global regulatory filing strategies for the client’s programs across the portfolio
Provide strategic regulatory leadership to project teams in early and late stage clinical development to advise on International filing requirements
Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle; this will include orphan designation requests, meeting briefing documents, and International Marketing Authorization Applications
Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
Prepare the client’s Global Regulatory and Program Teams for International Marketing Authorization Application and lead interactions with global health agencies
Coordinate responses to global health agencies questions with strict deadlines
Serve as a key liaison within internal departments at the client site, with CROs and with regulatory program managers at global health agencies
Maintain regulatory files in a format consistent with internal requirements
Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance
Supervise and mentor direct reports who will be managing other programs
Degree in Science or related discipline; PhD or PharmD degree preferred
At least 8 years of experience of working in one or more areas in Regulatory Affairs in the biotech or pharmaceutical industry
Sound knowledge and experience of Regulatory Affairs and associated requirements, plus pharmaceutical industry experience of clinical trial and drug development work with a track record of successful drug development through product approval in the US
Thorough knowledge of the drug development process
Experience in interfacing with ex-US and ex-EU Health Agencies
Must be able and willing to work in a high-visibility, fast-paced environment
Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
Works well on teams and on own initiative and prepared to take ownership and responsibility for his/her actions
Superior verbal and written communication skills
Results focused and able to meet deadlines
Experience with leading International regulatory filings, including electronic submissions, e.g., INDs, CTAs, NDAs, MAAs, annual reports, safety reporting, etc.
Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects
Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants
Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally
Adaptable and self-motivated, able to prioritize effectively with good problem-solving and planning abilities
Demonstrate clear alignment with the client’s Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
This position pays on a W2 hourly basis (no C2C or 1099's).
APPLY NOW for resume review by recruiter Pam Gewin!
IMPORTANT NOTE: All qualified candidates must successfully pass a background check and a drug screen to be considered for the position.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Clinical Trials / Clinical Studies