Senior Director, Regulatory Affairs
We are currently searching for a skilled professional to join a well-known client’s team as Senior Director of Regulatory Affairs. This position is located in Cambridge, MA. Reporting to the Senior Vice President of Regulatory Affairs, the Senior Director of Regulatory Affairs will work with a cross-functional team to implement regulatory strategy, data and submission packages to US and international regulatory agencies. Responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, active involvement in the writing and review of regulatory submissions and interfacing with authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements worldwide. The role requires an individual with demonstrated leadership capabilities who has led and managed an NDA submission, is self-motivated and independent, and is able to manage staff, work collaboratively, and can work and communicate effectively in a fast-paced environment.
- Provide innovative and strategic regulatory leadership to project teams in early and late stage clinical development for orphan diseases
- Work proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners to plan and execute an effective global regulatory strategy in alignment with the overall clinical development plan
- Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle, including briefing documents, INDs, and various designation requests
- Lead the planning, strategy, content and execution of NDA filing and follow through to approval
- Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
- Prepare the team and lead negotiations with FDA and other health agencies
- Provide regulatory due diligence as required
- Supervise and mentor direct reports who will be managing other programs
- At least 12 years of experience working in Regulatory Affairs; ideally 7 plus years in the biotech industry
- Sound knowledge and experience in Regulatory Affairs and associated requirements, plus pharmaceutical industry experience in clinical trial and drug development work with a record of successful drug development through product approval in the US
- Thorough knowledge of the drug development process
- Experience in interfacing with FDA
- Deep knowledge and understanding of global regulatory requirements and environment
- Demonstrated strategic thinking and implementation in overall drug development
- Must be able and willing to work in a high-visibility, fast-paced environment
- Must be detail-oriented, and possess good analytical and problem-solving skills
- Excellent verbal and written communication skills and strong interpersonal skills
- Ability to work independently with minimal supervision, and to take ownership and responsibility
- Ability to work cooperatively with teams and influence cross-functionally
- Results focused and able to work under pressure and meet deadlines
- Confident with the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally
- Demonstrated ability for innovative and flexible strategies
- Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
- Alignment with Client's Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
- University Degree in Science or related discipline; PhD or PharmD degree preferred
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.