Regulatory Affairs Specialist in Actalent at Silver Spring, Maryland, USA
Regulatory Affairs Specialist in Actalent at Silver Spring, Maryland, USA
Job Title: Regulatory Affairs Specialist
Employment Type: Permanent
Sector: Pharmaceuticals
Category: Healthcare
Location: Silver Spring, MD, US
Workplace Type: 100% Remote
Salary Min: $144,000.00
Salary Max: $216,000.00
See All 👉D.Pharm Alerts👈 👉B.Pharm Alerts👈👉M.Pharma Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈
See All 👉Other Jobs👈 in our Database
Additional Information Job Description Our client is looking for a Global US Regulatory Lead to lead and conduct biologic and/or non-biological product regulatory affairs submissions and documentation of US, EU and APAC regulatory documents for the FDA. 90% of the work is done in the US though, their team will sit in the EU. This person will lead the strategy to get the new product licensing with the FDA. This entity is a pharmaceutical in nature and not med device. Leading the negotiation with the FDA for licensing is a must. Cannot have done this in a supporting nature. Must be the main liaison for the FDA You will provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally.
· Has in-depth knowledge of best practices and how their own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market
· Provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, · Working closely with healthcare regulatory bodies globally Typically a 1st line manager of professionals or a 2nd line manager of a professional department.
· Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource.
· Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.
· Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience.
· May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus.
· Developing persuasion skills required to influence others on topics within field. Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team.
See All 👉D.Pharm Alerts👈 👉B.Pharm Alerts👈👉M.Pharma Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈
See All 👉Other Jobs👈 in our Database
Additional Skills & Qualifications
· Bachelor’s degree in a scientific discipline; post-graduate degree preferred.
· 10+ years’ experience of global regulatory affairs from the pharmaceutical and/or healthcare industry with a track record in key strategic roles.
· Experience of regulatory submissions and approvals in key regions such as EU, US and APAC, including new MAAs/NDAs.
· Significant experience of global regulatory project management and world-wide regulatory authority interactions.
· Experience of working with business leadership to define high level strategies.
· May have skills and knowledge in specialized areas key to specific business need, for example registration of oncology/immuno-oncology products or biologics.
· Maintaining a keen interest in scientific advances that impact healthcare product development and regulation. Change in indication Experience with Radio- pharmaceutics would be a huge plus Employee Value Proposition (EVP) Small team and growing. Ideal state is that by 2025 they have the first product through licensing. Without a US based SME, they will not be able to take on their US based needs as effectively as would be needed to hit their goals
See All 👉D.Pharm Alerts👈 👉B.Pharm Alerts👈👉M.Pharma Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈
See All 👉Other Jobs👈 in our Database
Work Environment Fully Remote Will be expected to travel to Marlboro, MA from time to time at their site. We try to limit on the size of the project with no more than 3 projects at one time.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
See All 👉D.Pharm Alerts👈 👉B.Pharm Alerts👈👉M.Pharma Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈
See All 👉Other Jobs👈 in our Database
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
See All 👉D.Pharm Alerts👈 👉B.Pharm Alerts👈👉M.Pharma Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈
See All 👉Other Jobs👈 in our Database
