Company: Pharmalink Consulting
Closing Date: 07 Nov 16
Salary (£): Competitive
Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients’ needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants. More: http://www.pharmiweb.com/Careers/results.asp?ROW_ID=854129#.V_d7gLvfPAU#ixzz4MOXCbqg4
Our Client has an exciting role for a Regulatory Affairs Manager is responsible for supporting, planning and executing regulatory tasks and activities associated with in-licensing and out-licensing opportunities. This role includes taking the regulatory responsibility for leading a project and may include developing regulatory strategy for projects.
The Regulatory Manager oversees the work load and interaction with third party ensuring commitments are met and regulatory data is exchanged. The
Regulatory Manager will manage obstacles and roadblocks, give clear direction, manage priorities and deliver project in line with business needs and commitments.
DUTIES & RESPONSIBILITIES:
•Designs and implements regulatory strategies to support in-licensing and out-licensing opportunities as well as managing transition phase of the project.
•Represents regulatory on key internal decision making teams, establishing strong partnerships with relevant stakeholder for example European and
•International Affiliates, Therapeutic Areas, Business Development, Commercial, Quality and Manufacturing and Supply.
•Functions as the regulatory lead for assigned projects including due diligence activities, leading/working with cross-departmental groups to drive global regulatory strategies.
•Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans.
•Identifies and assess regulatory risks associated with product development for assigned projects.
•Leads the development of regulatory strategic plans for integration/separation phase of Business Development projects.
•Actively works with the Regulatory Operations Management Team to ensure alignment of regulatory implementation associated with submissions.
•Provides guidance to all appropriate departments to assure compliance with applicable regulations.
•Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
•Effectively leads key meetings with third parties to ensure full discussion of regulatory issues and opportunities.
•Actively mentors junior staff; provides broader guidance on regulatory interpretation.
•Energetic, enthusiastic, good communicator, with good leadership, management and influencing skills
•Experience of managing staff and complex regulatory strategies.
•Clear and proven experience of people and performance management
•Clear and proven experience of managing and executing complex regulatory strategies
•Ability to operate at a strategic level across countries and contribute to the overall growth strategy of Clients
•Flexibility to thrive in a fast-paced, smaller Pharma company environment.
•Good understanding of the drug development process
•Good leadership skills with an ability to set a vision, lead change, and influence widely
•Strategic thinker with ability to develop and execute complex regulatory strategies
•Good interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals both within and outside the company
•Ability for sound business judgement and clear decision-making across diverse groups
•Good communication skills with an ability to communicate efficiently and productively both orally and in writing
•Drives performance and Works collaboratively;
•Maintains high ethical standards
•BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
•Must have Regulatory Affairs or equivalent experience. The regulatory experience should be broad to ensure appropriate leadership and mentoring for regulatory staff within Clients site.
•Proven management experience; or an equivalent combination of education and experience.
Vanwall Business Park
|Tel:||+44 (0) 1628 860300|
|Fax:||+44 (0) 1628 860400|
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