Job Title: Regulatory Project Manager – Pharmaceuticals Employment Type: Full-Time
Location: Remote (Available to travel to NYC for meetings)
My client is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. The company was established in the US in 1995, and has grown to more than 2,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region
DUTIES & RESPONSIBILITIES: Job Summary
- Be forward facing to clients providing project updates and translating project deliverables to teams across multiple cultures and experience levels.
- Define metrics and drive regulatory projects supporting multiple clients at a time.
- Act as a general regulatory Subject Matter Expert for pharmaceutical projects, with the support of project/topic specific experts on your global team.
- Provide a voice of motivation and support to teams. Provide creative solutions to regulatory or project hurdles.
- Provide Regulatory Guidance to entry level employees.
- Provide ad hoc regulatory support as needed to support on-going projects
- Grow client relationships through skilled and open conversations.
- Develop and execute project management tools for various regulatory projects. Create project plans and monitor smooth execution of plans at milestone and task levels.
- Collaborate and support the regulatory team and cross functional partners through the various processes
- Communicate with Clients to ensure expectations are met
- Work closely with Quality Assurance/Regulatory Affairs to ensure compliance to regulatory and industry standards and regulations. Ensure compliance to current regulation guidelines
- Assist with new hire onboarding activities
- Assist in the generation and monitoring of metrics, for dashboards, providing visibility of issues and enable corrective and preventive action to be taken as needed
- Participate in workshops and on initiatives to help define processes globally and keep abreast of regulatory requirements and industry trends/practices.
- Provide guidance on regulatory processes to assure timely delivery of projects in compliance with applicable Regulations & SOWs
- Support clients with Pharmaceutical Regulatory needs, such as but not limited to:
o With the support of a global team, provide oversight on global regulatory requirements for pharmaceuticals
o Review US and Global regulatory submissions for accuracy
o Provide guidance on regulatory strategy
o Support global registration for new and established products.
o Generate regulatory information packages to support multiple markets.
o Provide regulatory guidance and oversight to cross functional teams
o Conduct regulatory training for individuals having responsibilities with respect to consumer-facing communication to foster regulatory knowledge
o Prepare and submit product notification/registration with relevant authorities
o Monitor adverse events cases and liaise with Product Safety department
o Advise on ingredients and formulation to ensure product compliance with regulations at early stages of development, as well as on scientific data, consumer and clinical tests
o Maintain current knowledge of applicable regulations, participate in regulatory monitoring, identify risks and opportunities associated with changes
- Contribute to routine local process improvements, which have an impact on the Regulatory Affairs function.
- Participate in group meetings and provide tactical approaches to addressing issues of moderate complexity.
- Perform document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
- Ability to travel up to 10%.
Skills / Experience
- Bachelor or Master Degree in Science, Medicine, Pharmacology, Engineering, or equivalent
- At least 3 years’ experience with Pharmaceutical regulations.
- Experience with Pharmaceutical Regulatory submissions (IND, NDA, eCTD, ANDA, Annual Reports....) required
- Strong Project Management skills required, including experience in leading a team.
- Proficient in oral and written communication with good planning and organization skills
- Self-starter with an ability to work in team environment and on problems of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
- Strong communication skills, as well as strong meeting presence
- Use diverse experience to meet deadlines and be detail orientated
- Strong critical thinking and analytical skills required