Director, Regulatory Affairs, Biologics
- Expired: over a month ago. Applications are no longer accepted.
ClinChoice 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. ClinChoice 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. Please visit our website ClinChoice.com for our company information.
DUTIES & RESPONSIBILITIES:
As the Director of Regulatory Affairs for Biologics, you will have the opportunity to formulate and implement strategies to support multiple leading clients for various regulatory activities which could include cell and gene therapy. The role includes working with a broad variety of clients in various markets with the support of a global team. The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike. If you have a passion for regulatory affairs and building client relationships, this is the role for you.
- Provide strategic and tactical leadership of the regulatory affairs function in North America, in close collaboration with cross functional teams.
- Effectively collaborate with global leadership to seek out new opportunities for growth both with current clients and new clients.
- Act as SME with deep knowledge of FDA regulations for all aspects of regulations related to Biological products including Cell and Gene Therapy. Collaborate with internal staff to author and compile documents for submission to global regulatory agencies, including INDs, CTAs, BLAs, and MAAs.
- Provide consulting services within personal area of expertise this could include submission writing, conducting final reviews, and/or meeting with regulatory agencies on client’s behalf.
- With the support of a global regulatory team, act as lead point of contact and principal advisor to clients for all areas of drug and/or cell and gene therapy development.
- Produces quality work that meets or exceeds client expectations
- Contribute to business strategy discussions and implement regional and global specific objectives, as appropriate.
- Lead strategic initiatives and develop implementation plans taking ownership for final results and implementing process improvements where needed.
- Participates in preparing written and presented bid developments for new clients.
- Identify opportunities for business growth to ensure on going client support and positive engagement
- Provide input on business strategic plans and managing outcome.
- Understand project scope of work and contract negotiation to identify when contract need to be updated and ensure that SOW is being met throughout the project lifetime.
- Prepare and present client metrics as needed.
- Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
- Monitor Regulatory environment and communicate any changes and impact assessments to all team members.
- Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.
- Mentor internal team across various regulatory projects.
- Hire, develop and mentor regulatory personnel and future regulatory staff.
Experience & Qualifications:
- Bachelor’s or master’s degree in a scientific field.
- At least 8 years of regulatory experience with at least 3 years in Biologics
- Experience in dealing with the FDA and international regulatory authorities.
- Experience in all aspects of regulatory affairs including CMC, Clinical, and post market commitments.
- Experience with submission writing such as INDs, MAAs, BLAs, etc..
- Direct experience working with the FDA and other health authorities highly desired.
- Demonstrated ability to manage regulatory activities and deliver against project timelines.
- In-depth understanding of the product development combined with experience in Quality Assurance, Clinical and Compliance is desired.
- Must be able to interpret trends in the US healthcare regulatory environment that directly affect business decisions in the industry.
- Established leadership and management skills with cross-functional teams in a matrixed organizational structure.
- Strong leadership, strategic orientation, development of people, and process.
- Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
- Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
- Experience in a setting up a department is preferred. Must be comfortable with ambiguity in a small, fast-paced environment.
ClinChoice is an Equal Opportunity Employer / Committed to Diversity
AddressFort Washington, PA
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