Regulatory Affairs Consultant
Cambridge Metro Area, Massachusetts
1 Provide a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, developing innovative solutions to minimize costs, yet deliver on company strategies and proactively influencing the global regulatory strategy.
2 Contribute to company Global Regulatory Strategy through participation on the Global Regulatory Affairs Leadership Team (GRALT) and SMRT.
3 Work closely with the Global Head,l Regulatory Affairs to maintain an effective Global Regulatory Affairs organization.
4 Provide strategic leadership of product development and registration projects to meet the global business objectives for the region.
5 Actively contribute to the global regulatory community through designated projects. Build and maintain relationships with Global Regulatory Affairs at different sites across the organisation.
6 Ensure and monitor local registration activities including the development of processes to ensure efficient and timely registration of new products and maintenance of existing products.
Ensure strategic input from the Americas Region is provided at GRAST meetings and key information/learnings from GRAST meetings shared back
7 Ensure the timely and efficient identification of regulatory risks associated with the products and issues relating to emerging regulatory environment changes and escalation to Global Head of RA and as appropriate to senior management.
8 Ensure high quality, right first time submissions in line with corporate objectives; managing major and minor applications to meet business objectives and timelines with competitive outcomes in the region.
9 Oversee the development of strong working/partnering relationships with key agencies in the region, usually working through the local country regulatory managers/consultants (i.e. FDA, Health Canada(BGTD),LATAM (ANVISA etc))
10 Full compliance with all government regulations and corporate policies including oversight of corrective actions for which the regional regulatory team is accountable
11 Single point of contact for integration of Regional, Country and Business Unit regulatory activities. A recognized regional partner for other regional focused business activities and initiatives
12 In collaboration with Healthcare Policy and External Affairs, advocate by building strong relationships with key external stakeholders (e.g. trade associations and professional bodies). Work externally to influence the regulatory environment and where appropriate CSL policy priorities
13 Direct working relationships with the regional/global clinical and technical R&D associated assigned with the region
14 Direct the growth and professional development of the regional Regulatory Strategy team members, including succession planning for critical roles with the regional and global regulatory leadership
15 Regional Heads Coordinator: establishes and leads a regional forum consisting of all GRA Region Heads to align on direction and priority for GRA policy activities.
16 GRA External Relations & Policy Coordinator: sets direction for GRA policy activities and coordinates trade association engagement and direction with Healthcare Policy and External Affairs, drives global regulatory advocacy activities by building relationships with key external stakeholders (e.g. trade associations and professional bodies) in collaboration with other Region Heads and the Global Head of RA
18a Manage activities of the Region including resources, budgets, information management systems and planning in line with the Global Regulatory Affairs activities
18b Driving Performance
Sets clear expectations/objectives aligned with Company Objectives
Provides an appropriate balance of direction and support to manage the performance of direct reports
Holds people accountable for their performance and coaches individuals as needs to ensure they contribute at the right level
Evaluates performance, gives feedback and recognizes results
Ensures operational efficiencies that contribute to our bottom line
18c Building Productive Teams
Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions
Builds a productive, engaging team culture and climate based on trust, respect and mutual support
Clarifies team roles, goals, mission and ground rules
Builds networks with other teams to support business objectives
When required, uses appropriate approaches to build virtual, cross-cultural and/or cross-functional teams
18d Developing People
On-boards new hires
Recognizes and develops the potential of direct reports
Holds professional development and career discussions with direct reports
Provides opportunities for team members to learn and grow
18e Creating the Future
Serves as a role model for CSL s Values (Customer Focus, Innovation, Integrity, Collaboration, Superior Performance)
Understands the mission, vision and strategy, and develops action plans to drive strategy execution with specific reference to the strategic objectives
Is dedicated to fulfilling the needs of internal and external customers and stakeholders
Challenges the status quo; fosters innovation and continuous improvement
Applies business acumen skills to help grow the business
19 Site Head Role
Perform Site Head duties, including be GRA local contact at the site for site related topics (e.g. coordination of office space, ensuring that GRA staff work practices are in line with HSE requirements and initiatives, local HR related projects etc.) and fostering close collaboration between the GRA departments at the Site.
Stays in close contact to the GRA leaders to support them in their direct leadership role for local staff, including support during hiring process and by providing feedback for IPM.
Responsible for budgeting of any site related cost centers with input from other GRA heads as applicable
Position Qualifications and Experience Requirements:
A degree in Biological or Medical Science or Pharmacy, preferably with a post graduate qualification
At least 10 years of regulatory experience, supported by additional pharmaceutical/industry experience
Extensive experience at a senior level in Regulatory Affairs, with a strong knowledge of regulatory affairs legislation and processes in the US
Demonstrated experience across drug development and commercialization lifecycle, with proven examples of contribution
Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities with biological products
General management experience with line management and leadership at senior management level is essential
Demonstrable experience of effective delivery of objectives in a complex matrix environment
Demonstrable experience in establishing and building a high performing team essential, and specifically a RA team highly desirable
Superior strategic and tactical thinking ability, complemented by a hands on operational and business planning orientation
A balanced technical understanding of products and processes combined with superior business, regulatory and compliance acumen
Sound judgment and strong analytical skills, for implementing risk-based oversight programs
Proven track record of demonstrating collaboration and influencing skills across the organization at all levels
Through understanding of how regulatory bodies approach dossier reviews, pre-approval and post approval inspections and of how to respond to Health Authority observation is required
Excellent communication and interpersonal skills to ensure positive working relationships are developed and maintained with internal and external stakeholders, and bodies
Ability to lead, drive and motivate people to achieve goals
Ability to support and foster a diverse and multicultural group
Sound presentation skills
Flexible and adaptable attitude with the ability to introduce and manage change
Role model and promote values:
o Customer focus
o Superior performance