Senior Regulatory Affairs Manager

Job Title:                   Senior Regulatory Affairs Manager

Department:              Regulatory Affairs

Job Holder:              

Reports to:                Project Director        

 

Number of Direct Reports: 0          

 

MAIN PURPOSE OF ROLE:

 

Collaborate in a team that works across the unit and organisation to:

  • Perform and be part of the Regulatory Affairs department  
  • Execute project related activities
  • Support business development activities for the current and future clients by providing technical information
  • Work cross-functionally and in collaboration with key stakeholders/customers both internal (eg, Commercial, Technical, Quality, Pharmacovigilance, etc) and external (eg, Competent Authorities, Clients, External Vendors, etc)

 

KEY RESPONSIBILITIES:

  • Execute and have the overview of the Regulatory activities, which includes but not limited to:
    • Life-cycle management of licenses
    • Filing applications in various regions for MA granting
    • Proactively suggest activities based on local knowledge and experience
    • Negotiations with the competent authorities

 

  • Deliver facilitating and enabling solutions to add new business opportunities for current or future clients
  • Lead delivery of required service levels from the respective Regulatory partners and take remedial actions as needed
  • Ensure high level delivery internally that adapts to changing requirements
  • Identify gaps and areas for improvement and lead remedial actions and initiatives
  • Participate at industry events and trainings when required
  • Participate during any related business activities, ie meetings with clients, trade shows, etc
  • Adhere to company’s processes and systems
  • Liaising with Pharmacovigilance Department for the update of the information on licenses and exchange of important information

 

KEY ACCOUNTABILITIES:

  • Excellence in delivering projects to clients
  • Delivering solutions to issues in collaboration with partners and internal stakeholders
  • Precise alignment with Regulatory (and other) partners in respect of on-going and required activities
  • Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication.
  • Excellent cross-functional teamwork with Operations colleagues to ensure full compliance

 

PERFORMANCE STANDARDS:

High Regulatory compliance levels

No preventable regulatory cause for customer complaints

Meeting the milestones and deadlines in accordance to quality and time


 Senior Regulatory Affairs Manager

 

Requirement

Essential

 

Desirable

 

Qualifications:

 

 

Bachelors degree in Pharmacy, Engineering  or Life Science

Graduate qualification in a relevant scientific discipline

 

 

 

 

X

 

X

 

Experience & Competences

 

 

Significant Regulatory Affairs experience across EU and any other markets within the Pharmaceutical Industry

X

 

 

Previous line management and leadership role

 

X

 

Proven change management experience

 

X

 

Experience of working with external suppliers and partners

X

 

 

Relevant EU and/or other markets Regulatory Affairs training

X

 

 

Knowledge & Skills

 

 

Regulatory requirements across EU and/or other markets

X

 

 

Ability to work cross-culturally with external partners and agencies

X

 

 

Ability to work collaboratively and in a cross-functional environment

X

 

 

Customer-focused

X

 

 

Ability to recognise new business opportunities

X

 

 

Innovative solution finding

X

 

 

Strategy setting, planning and implementation

X

 

 

Influencing and negotiating

 

X

 

Excellent attention to detail

X

 

Personal Qualities

 

 

Motivating department to ensure a high level of performance

Positive can do, will do attitude. Wanting to progress the department forward, by doing the job to the best of your ability

Role model of desirable behaviors and ways of working

Working with integrity, believing truth matters and acting with positive motives at all times.

Calm and forward thinking in their approach

Sets ambitious goals and high standards

Strives for quality and eliminates mediocrity

Approaches work with a sense of urgency

Commits to action and implements promptly, does not postpone issues

Contributes to the recruitment, identification and development of talented individuals

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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