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Associate Director, Regulatory Affairs (Home or Office Based)
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OUR CULTURAL BELIEFS
Patient Minded I act with the patient’s best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and empower others to act now.
Grow Talent I own my development and invest in the development of others.
Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
Own It I hold myself and others accountable for results.
The most important aspect of the position of the Assistant/Associate Director of Regulatory Affairs is being responsible for managing the more complex regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies worldwide, with an emphasis on FDA premarket submissions. This person will assist the Regulatory Affairs Director or VP of Regulatory Affairs in the development of appropriate responses to FDA enforcement actions (e.g. Warning Letters Responses).
POSITION SUCCESS FACTORS
- Ability to work with internal employees and external clients simultaneously
- Ability to manage multiple projects and deliverables in a timely fashion
- Regulatory Lead on product development team(s) in some cases, in others based upon experience and level of complexity of the technology might work under direction of a more senior or more qualified Regulatory Lead. Provides regulatory input and advice and ensures regulatory compliance throughout the product lifecycle. Defines regulatory submission strategies throughout product development; manages submission timelines, interprets applicable regulations and guidelines for product team use; keeps project team and EVERSANA management informed of regulatory decisions, issues, potential problems, and new regulations.
- Works closely with other Company department leads to ensure regulatory compliance in the requirements and preparation of submissions to FDA and international regulatory authorities.
- Coordinates timely submissions and amendments consistent with company strategies, regulatory requirements and timelines. Areas of expertise include preclinical, clinical, labeling development, and safety reporting.
- As appropriate, manages the entire meeting process with relevant regulatory authorities- including submission of request, coordination of briefing package preparation, meeting facilitation, and minute compilation.
- Communicates with regulatory authorities as needed.
- Prepares and writes complex submissions and other regulatory filings as required.
- Evaluates new regulatory intelligence, including new and revised regulations and guidance, assesses potential impact on the organization and communicates to Senior Management
- Ensures all clients and DLSS management are immediately and properly informed of any regulatory, compliance, project, or personnel risks to projects, processes, and to the organization.
- Monitor new drug, biologic, medical device approvals in relevant therapeutic areas and communicate appropriately.
- Evaluate and recommend project specific regulatory filing strategies.
- Cross functional collaboration to ensure corporate objectives and milestones are met in a timely manner.
- Prepare policies and SOPs in accordance with company and regulatory requirements.
- Assisting the VP of Regulatory Affairs and/or Regulatory Affairs Director with other duties as assigned.
- Managing, training and mentoring regulatory associates and/or quality specialists.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
- Minimum 8 years’ experience in a medical device, pharmaceutical or biotechnology company; possess substantial knowledge of FDA, medical devices, and ISO regulations for device manufacturing.
- Or a Master’s degree in a related discipline with 4 years regulatory affairs experience.
- Possess Undergraduate science based degree;
- RAC certified professional not required but a bonus
- Project management skills.
- Experience in dealing with FDA, Notified Bodies and other regulatory agencies Working knowledge of ISO and applicable International regulations, compliance and audit practices.
- Experience managing technical resources.
- Strong negotiation and influencing skills.
- Strong communication skills (verbal and written) in both casual and technical communication situations.
- Proficient in Office programs including Word and Excel.
- Travel required - consistent with customer needs up to 100% at times if necessary.
- Self-motivation, good judgment, strong follow up, organizational, analytical, and problem-solving skills
- Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision.
- Ability to translate technical knowledge into appropriate regulatory strategy/actions
- Ability to determine compliant risk based options
- Attention to detail
- Organizational skills
- Timeliness of deliverables under tight timelines
- Able to work with direction that is not always specific, but asks for assistance if direction is not understandable
- Able to explain reasoning that led to conclusions both orally and in writing