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Director - Regulatory Affairs

Mangalore, Karnataka

Synowledge PV Services India Pvt Ltd 

Job Description

The Director- RA position is responsible for the entire Regulatory function in India.
The Director- RA will act as the single point of contact for number of Bioclinica accounts that provides Regulatory services and solutions to client. The Director- RA will be responsible for acting as the point of contact between the Clients and the Bioclinica India delivery project team. He/She will manage all client expectations, requirements, and relationships to ensure successful delivery of services and expansion of business.
The Director- RA will have the objective to expand the current scope of services and acquire additional business by identifying areas of opportunity within other departments and complementary service lines. He/she will have Account Management responsibilities for existing and potential customers.
The Director- RA will also work with the Business Development and Marketing teams to close new business and win new clients throughout Europe/US. He/she will have direct involvement in meetings with clients and potential customers to present Bioclinica capabilities and demonstrate our expertise to attract and win new projects. The Director- RA will provide their expertise and guidance to the Client Relations team on all industry regulations, best practices, and technical subject matter.
Account Management:
Ensure Customer Satisfaction is met at all levels for responsible Bioclinica accounts
Form strategic relationships with contacts in other departments/groups of interest to expand account scope and grow business
Ensure all project deliverables and timelines are met on a consistent basis
Have a thorough understanding of all client/project requirements at all times
Effectively handle all escalations from both client and Bioclinica team
Maintain clear and direct lines of communication throughout all involved departments to meet customer requirements
Address all client concerns related to the project and implement corrective and preventative action plans as required
Identify areas of expansion to grow existing client accounts and increase revenue
Work with Client Relations and Delivery departments to consistently update management on status of account(s) and areas of opportunities
Pursue new business through client acquisition in allocated territories
Promotion of partnership
Develop case studies, white papers, etc. (in coordination with Marketing)
Arrange promotional cross-departmental events with Client to expand network into other areas of interest (i.e., lunches/dinners/seminars with PV Department, IT, etc.) to promote the success of the project and our complimentary services offered

Life Sciences Expertise:

Assist Client Relations team during client meetings and teleconferences by providing industry expertise and guidance on Industry Trends, Services/Solutions expertise and industry best practices
Provide input and assistance with the preparation of proposals, Power Points and other sales/marketing collateral and documentation
Attend bid defense meetings and represent Bioclinica as a Client Relations representative
Identify strategic growth areas for company as per industry trends and opportunities
Provide industry expertise at webinars, seminars, conferences, and other industry events

Specialized Skills and Knowledge:

Strong experience/knowledge in Regulatory Affairs and Project Management
Experience in Services Sales/Delivery of Small, Medium, and/or Large sized outsourcing projects in the Life Sciences and related industries
Excellent relationship management skills
Strong project management skills, with a keen desire for execution
Strong analytical and strategic thinking abilities

Communication skills:

Requires a proactive approach and excellent written/oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross department communication.
Ability to document and communicate problem/resolution and information/action plans.

Other skills:

The ability to contribute to a team environment with a high degree of professionalism and skill.
Demonstrate flexibility within a dynamic, fast-paced, cross-functional team.
Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
Ability to perform under stringent timelines.

Company Description

Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
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Additional Information

Last updated:
Job type:
Full time
Position type:
Minimum experience:
Between five and ten years
Compulsory Education
Jobs in Healthcare / Medical / Pharmacy
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