Manager / Senior Manager - Regulatory Affairs

The purpose of the Affiliate Regulatory Affairs role is to manage the operational and technical aspects of regulatory affairs for the marketing affiliate, including:

Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and
quality system requirements.
Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve Affiliate regulatory objectives.
Facilitate and cultivate relationships with the local regulatory agency/MoH.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional
responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory Plan Execution
Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements.
Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables.
o Preparation and support of new applications to obtain marketing authorisations.
o Voicing affiliate perspective and needs to global and regional regulatory contacts.
o Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
o Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
Maintain Regulatory Tools in alignment with defined compliance metrics.
Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans.
Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions
Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and
implement locally.
Facilitate interactions with regulatory bodies on a regular basis.
Regulatory Compliance
Ensure that internal Regulatory IT tools are up to date and accurate.
Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available.
Ensure implementation of local quality system in line with the global quality system and local regulations.
Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.

Implement corrective/preventive actions as appropriate.
Provide regulatory quality oversight for Third Parties (ie Regulatory Services Providers, Translators, Graphic Agencies, etc) as appropriate.
Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.
Labelling
Perform the function of Primary, Alternate or Delegate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.
Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labeling

Process Improvement
Ensure alignment and implementation of internal regulatory initiatives.
Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge.
Support implementation of launch readiness initiatives.
Build and maintain relationships with key regulatory officials (External Influence).
Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives.
Personal and Professional Development
Knowledge and understanding of local regulations and local, regional and global regulatory procedures.
Attend appropriate external symposia, workshops or conferences to develop technical expertise

Optional Responsibilities: This section is intended to provide additional responsibilities the position may require depending on the Affiliate structure and/or local requirements. Consult with your supervision regarding these additional
responsabilities in order to confirm which ones apply to this position. It may apply all or some of them.

Note: If the individual undertakes actual responsibilities as Pharmacovigilance Responsible person or Product Quality Representative, then the relevant functional Job Description should be followed

Patient Safety
Assist the Affiliate Pharmacovigilance Responsible Person in reporting received Adverse Events and submitting expedited and periodic safety reports to the Agency/MoH as per local regulations.
Product Quality
Assist the Product Quality Representative with the implementation and execution of Lilly Global Quality Standards in particular GQS-181/CQP-181 in the affiliate. Identify and support Product Quality tasks and, in collaboration with the
Product Quality Representative, act as the local Quality contact.
Support the Product Complaint system as local Responsible Complaint person.

Minimum Qualification Requirements:
Bachelors degree or equivalent in a relevant scientific subject
At least one year industry related experience in regulatory affairs and experience of dealing with external regulatory
agencies, the health care system and marketing needs.
Team working skills with special focus on results.
Ability to adapt to challenging situations.
Demonstrated good computer/IT skills.
Good knowledge of written and spoken English.

Other Information/Additional Preferences:
Analytical, problem solving and negotiation skills.
Good communication skills.
Project management skills.
Strong planning and priority setting.
Good capability to establish positive networking both internally and externally.
Strong knowledge of quality systems