Role posted on: 15th April 2019
G&L have multiple opportunities for Program Managers with previous experience of oncology portfolios. We offer completely flexible working conditions – either at one of our multiple locations across the globe or with home-working arrangements. Our current openings are working with one of our most valued and established clients – a industry leading biotech organisation.
Our team of Regulatory Program Managers are tasked with interpreting the needs of worldwide health authorities and providing regulatory intelligence to generate and present information which meets the needs of health authorities, patients, purchasers and prescribers for our client’s global pharmaceutical medicines division, which includes all therapeutic areas and all phases of the product life cycle from early development to post-marketing. This team is responsible for the timely submission of applications to health authorities for approval of new products and line extensions.
Our client is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory program management, this team of managers are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Our managers support regulatory program management for one or more development projects. You would participate in and support the development and implementation of regulatory strategies to facilitate the development and approval of medicines for human use. Our program managers are expected to perform their responsibilities with supervision and work cross-functionally to help coordinate regulatory-related activities across all functions and with other internal partners.
Role Description: Regulatory Program Manager – Oncology, global positions
The role will include the following activities/duties:
- Stays abreast of internal and external developments, trends and other dynamics to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
- Obtains and applies in-depth knowledge of company and regulatory guidelines, procedures and best practices
- Stays abreast of therapeutic area product development and other related business strategies and plans
- Supports on one or more regional projects at any one point in time
- Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
- Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
- Supports Regulatory program management Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
- Supports Regulatory rogram Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
- Documents meetings, teleconferences and other interactions/communications with regulatory authorities
- Supports Regulatory program management Directors in providing internal teams with direction on regulatory authority interactions
- Providing ongoing guidance on regulatory deliverables, compliance, timing and other relevant matters. Helps manage resources, including documenting meeting minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
- Helps manage project plans and timelines for assigned projects
- As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
- Supports program directors with a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation. Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and company standards
- Supports effective, best-practice maintenance of various clinical and non-clinical regulatory documents
- Helps Regulatory Directors manage all deliverables associated with each project or other assignment to ensure these are completed within defined timelines and meet regulatory and other company guidelines
- Participates in and supports development of regulatory risk management and contingency plans. Develops associated communication plans for Regulatory program Directors and their internal distribution
- Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
- As requested or otherwise appropriate, supports Program Directors in providing regulatory due diligence assessments in cooperation with other internal groups
- Bachelors Degree required (life sciences disciplines strongly preferred)
- Advanced Degree in related field is preferred
- Average of 3 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
- Demonstrated understanding of international regulations, processes and issues in drug/biologics development. Includes sound knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
- Demonstrated experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Demonstrated understanding of product and safety profiles
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Fluent English and other language skills as needed
- You should have impeccable ethics. You should be able to demonstrate our company values and have leadership and influencing skills
- You should have outstanding attention-to-detail
- Your previous experience should include working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g., clinical development, clinical operations, biostatistics, commercial operations, etc.
- You should have excellent project management skills: able to prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
- You should have good interpersonal and verbal communication skills, as well as strong written communication skills
- You should have good business presentation skills; be comfortable and effective when presenting to others, internally and externally
- You should have good negotiation skills: know how to complete deliverables by working effectively with others internally and externally
- You should have good judgment and decision-making skills: know how to make trade-off decisions while balancing ethics and efficacy
- You should work well within teams and be effective in collaborating with others internally and externally
- Ability to travel (<10%)
If you would like to hear more, please send your details to talent @ gandlscientific.com today!
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.