Associate Director - Regulatory Affairs

Kelly Scientific Resources
South East England
Not specified
19 Jul 2017
16 Aug 2017
Contract Type
Full Time
Kelly Scientific are working with a global pharmaceutical company in their search for 2x Associate Directors in Regulatory Affairs to be based in the London office on a contract basis for an initial 6 months. The purpose of the roles is to provide regulatory expertise for multiple projects to ensure deadlines are met and all standards are met. There will also be some international travel required as part of this role (
Further Responsibilities
* Leading the regulatory working team globally or for own region to ensure the regulatory life cycle strategy is managed effectively
* Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region of responsibility
* Identifies relevant global /regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project of responsibility. Authors and reviews global and/ or regional regulatory strategies as well as executes day-to-day activities for projects or may delegates to staff and / or vendor with oversight.
* Usually includes supervision of one or more direct reports and / or vendor activities.
* Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of project team as necessary.
* Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
* Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve company strategic goals and objectives.
* Identifies regulatory requirements and trends across area of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas, as requested.
* Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
* Presents to senior management as requested.

* BSc degree or equivalent in science; advanced degree preferred.
* Considerable pharmaceutical industry experience (6 years+). This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases. This role is a Senior level position, candidates must be able to demonstrate strong understanding of the regulatory life cycle within the pharmaceutical industry.
* Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets preferred.
* Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
* Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
* Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
* Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
* Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership.
* Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.
* Experience in managing personnel a plus; experience managing relationships with CROs and/or contractors also preferred.

Kelly Scientific are acting as an Employment Business in relation to this vacancy.