Reference Number: JO-2311-526452
Regulatory Affairs Senior Manager
Job Type: Contract
Regulatory Affairs Senior Manager
Contract Length: 12 months
Flexibility: Onsite 2x per month
Salary: £45-£60 per hour
CPL have partnered with an established multinational biopharmaceutical company to aid the expansion of their Regulatory Affairs team based in the UK. This management role would involve assisting the Director of Regulatory Affairs and requires an individual that is comfortable working independently and also in a team.
Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all of the companies molecules.
• Assist in aligning local regulatory requirements with corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and standards and procedures.
• Act as the point of contact with regulatory agencies.
STRATEGIC AND EXECUTION
• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• With minimal supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
• Ensures regulatory submissions are made on time and meet corporate and local regulatory requirements.
• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
• Reviews and approves the promotional and non-promotional materials.
• Monitors changes in the local Trade Associations /national legislation and forwards information to local/regional groups communicating the impact to the company.
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
HEALTH AUTHORITY INTERACTIONS
• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Participates/contributes to local agency interactions and their preparation
COMMUNICATION AND COLLABORATION
• Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
• Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
• Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all the companies molecules.
• Partners with peers to ensure consistency on procedures.
• Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).
• Establishes regular contacts and interactions with Distributors (if applicable).
• Provide SME support in AFP and other projects initiatives.
COUNTRY SPECIFIC ACTIVITIES
• Assists locally in Healthcare Compliance activities where applicable.
• Participates in local regulatory process improvements, initiatives and training.
• Oversees external vendor/contractor relationships where applicable.
Knowledge and Skills
Scientific and Technical
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• Good knowledge of national legislation and regulations relating to medicinal products.
• Awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
• Demonstrate strong team work ability.
• Good communication skills – both oral and written.
• Good negotiation and Influencing skills.
• Ability to understand and communicate scientific/clinical information.
Education & Experience (Preferred)
• Degree and in-depth regulatory experience and/or related to the country(ies).
• Depth knowledge of country(ies) legislation and regulations relating to medicinal products.
If you believe you are suitable for this role or would like to find out more information, please contact me on the information listed below.