We are looking for a talented and motivated regulatory affairs manager to provide regulatory support for developmental products and to oversee the process for the filing of regulatory documents internationally. This involves collaboration with and coordination of cross-functional project teams for timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight.
Primary Duties and Responsibilities:
- Reporting to the Director of Regulatory Affairs, the Manager will support day-to-day regulatory activities of assigned projects. These include but are not limited to:Support of preparation, reviewing, compilation, and execution of submissions for regulatory agencies for US and ROW ((e.g., IND, INN, NDA, CTD, CTA, IMPD, MAA, Drug Master Files, DSUR, Annual Reports, Amendments, Supplements, and Responses to Agency feedback, etc.)
- Provide Regulatory support for assigned clinical studies
- Management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.
- Drafts and reviews Regulatory Affairs' SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required
- Supports other projects as needed, which will include but not be limited to performing research and compiling materials to develop regulatory strategies.
- Solves problems of moderate levels of complexity following established company policies and procedures.
- Follows general instructions to complete projects.
- Capable of working independently to complete mid-level assigned projects.
- May be responsible for conducting performance reviews and providing feedback and coaching to direct reports. Other duties as assigned.
Other Duties and Responsibilities:
- Supporting the Regulatory department across a number of company-sponsored projects.
- Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
- Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Communication/Presentation Skills: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences.
- Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
- Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
- Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
Education, prior work experience, and specialized skills and knowledge:
- A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted.
- A minimum of 5 years pharmaceutical industry experience and a minimum of 3 years experience in Regulatory Affairs is required.
- Minimum of 5 years hands-on Regulatory Affairs experience, in either drugs and/or medical devices is required.
- Thorough understanding of major FDA, EMA, ICH guidelines and evolving regulatory landscape and knowledge of GCP and Quality requirements required.
- Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills.
- Must be highly organized, detail- and goal-oriented, quality conscientious, and customer-focused.
- Must be able to adhere to strict project timelines.
- Experience in working in a multi-disciplinary team environment is preferred.
- Ability to adapt to changing priorities and to manage multiple tasks is required.
- Strong computer skills in Word, Excel and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset.
- Expected to maintain current awareness of US, and knowledge of ROW regulatory requirements, guidelines and regulations (i.e., cGXP).