|Job Title||Regulatory Support Specialist|
|Job Type||On Contract|
Credevo is a global consulting organization supporting healthcare product development from clinical development to commercialization. Credevo provides strategic support in areas such as regulatory, clinical development, licensing (out-/in-), and feasibility support, for products including pharmaceuticals, biologics, nutraceuticals, and medical devices.
The Regulatory Support Specialist (RSS) will work in close coordination with the company’s CEO and will be responsible for product registration; managing regulatory compliances, regulatory database, clinical trials, client, vendor, and regulatory authorities relationship for the company’s client project. RSS will assist in the business development, marketing, proposal submission and promotional services.
Essential duties and responsibilities (included but not limited to)
We are looking for an incumbent who can perform the following activities while working remotely:
- Management of new project requests and inquiries received from clients
- Development of new capabilities and Credevo’s service offerings, including but not limited to CTD and eCTD.
- Coordinate, prepare, or review regulatory documents or submissions for various regulatory projects.
- Coordinate and communicate with clients, vendors and regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Identify required documents, relevant guidelines and regulations, international standards, or consensus standards required for new projects and provide interpretive assistance
- Maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Research and advice on matters related to changes in regulations, processes and applicable policies.
- Interpret regulatory rules or rule changes and ensure that they are communicated to clients and updated in a timely manner in the internal database.
- Assistance with the business development, marketing, proposal submission and promotion of Credevo’s services offerings
- Any other duties assigned from time to time.
- Bachelor’s degree in Healthcare, Life Sciences, Pharmacy, biochemistry, biological, medicine and other related fields or equivalent education sufficient to successfully perform the essential functions of the job is required.
- Masters or higher degrees will be an added advantage.
- Certification in Regulatory Affairs will be beneficial but not required.
- Prior Work Experience: At-least 2-5 years of experience working as regulatory specialist in medical / clinical research/ pharmaceutical organizations, consulting firms etc.
- Job Knowledge:
- In depth knowledge of regulations and standards applicable to healthcare products like medicines, medical devices, nutraceuticals, herbals and cosmetics for various geographies.
- Working knowledge of and ability to prepare regulatory documentation, including but not limited to various sections of regulatory submission, in compliance with applicable regulatory requirements.
- Qualified within the Regulatory function with at least limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function.
- Demonstrated ability to coordinate with and maintain a clear, consistent, crisp, and timely communication with clients, vendors and other stakeholders.
- Demonstrated ability to identify, select, and qualify related vendors in a timely manner.
- Ability to coordinate and communicate with regulatory authorities for submission of applications, enquiries, or other relevant matters.
- Skills & Abilities:
- Extensive knowledge of applicable federal and state regulations and the ability to stay current on regulations.
- Excellent written and verbal communication skills.
- Ability to forge team bonds, develop working relationships and contribute in team building to ensure a productive and successful working environment.
- Excellent analytical and problem-solving skills.
- Proficient with Google Suite or similar software.
- Flexibility to work at different hours of the day, depending on your time zone and vendor’s/ client’s time zone.
- Able and willing to engage in meaningful, crisp and productive conversations on video, audio and personal meetings.
- Possess ability to prepare clear, meaningful and crisp documents like reports, manuals, proposals etc, without grammatical, spelling or other errors, based on given details and instructions.
- Able to work comfortably on spreadsheets (google spreadsheets) – with formula, functions and other modules in the spreadsheet.
- Quick learner and work well without constant supervision.
- Expert ability to search various sites and sources to gather information, process the results obtained and prepare conclusions.
- Ability to understand and comprehend the needs of the work and cooperate well.
- Language Proficiency: Expert written communication skills in English language – This should be demonstrated by prior work and during the selection process. Good English speaking skills with ability to understand different international accents is also required.
IMPORTANT: You will need to login to your gmail / google account for authentication to apply.