Regulatory Affairs Specialist

About Job:

The Regulatory Affairs Specialist will be responsible for leading a subset of the Business Unit portfolio of development and marketed products in one or several therapeutic area(s). In this capacity, he will be accountable to the Head of Regulatory Affairs to lead the development and implementation of regulatory strategies and collaborate with cross-functional teams throughout the product life cycle to support the business objectives while ensure compliance with the local regulations.

Main Responsibilities:

• Serve as the primary regulatory affairs focal point for the assigned portfolio with internal stakeholders, including Marketing, Medical Affairs, Market Access, Quality, Pharmacovigilance and Supply Chain.

• Lead and contribute to the regulatory strategy development and implementation for new product registrations in GCC countries in alignment with the cross-functional and brand team.

• Collaborate with global and regional regulatory teams to align on the planning and implementation of regulatory strategies for the assigned portfolio.

• Plan for preparation/review and submission of all maintenance activities and new applications based on company plans and agency guidelines, including working with Submission Excellence team.

• Ensures Regulatory labelling compliance and submission of safety updates in line with Health Authorities requirements and internal compliance deadlines.

• Maintains knowledge of regulatory requirements up to date and provides regulatory intelligence and guidance on changes in the regulations and guidelines including assessment of their impact on Sanofi's portfolio and business.

• Manage regulatory agency interactions, align with GRLs on communication strategy and coordinate correspondence with the Agency, proactively preparing the team and addressing any queries from the agency while facilitating effective communication practices.

• Working closely with Pharmacovigilance & Medical to ensure timely submissions & follow up on products alerts & periodic reports.

• Working with internal stakeholders in preparation, submission and follow up of pricing, internally and externally, as per local processes.

• Working with Supply Chain & Quality to report shortage alert to Health Authorities.

• Work closely with supply chain to ensure labelling implementation compliance.

• Grant HA approval to import certain quantity of product to avoid possible shortage if needed.

• Communication with our local agents and distributors in Gulf to achieve successfully submission, follow-up and approval of all regulatory activities managed by the Health Authorities in Gulf Countries.

• Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.

• Review and approves promotional material and activities in accordance with national legislation and Codes of Practice and company policies and procedures.

• Adhere to internal policies, procedures, and all applicable regulatory requirements, decisions, and decrees.

• Maintain effective communication with local, regional, and corporate teams to ensure regulatory alignment and support.

• Abide by the requirements of the internal and local Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company.

Ethical Leadership

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.

• Escalates any decisions or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role. Environmental and Safety Leadership To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work.

• Support and conform to Company HSE rules and procedures to ensure a safe, healthy, and pollution free work environment.

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Qualifications

• University degree, preferably in life science preferred MD, PhD, PharmD, Advanced degree preferred.

Experience & Knowledge

• 5+ years’ experience in Regulatory Affairs in pharmaceutical industry.

• GCC knowledge and experience is preferable.
  

Key Competencies:

• Support and conform to Company HSE rules and procedures to ensure a safe, healthy, and pollution free work environment

• Strategic thinking and business acumen

• Strong communication and negotiation skills

• Problem-solving and decision-making

• Support and conform to Company HSE rules and procedures to ensure a safe, healthy, and pollution free work environment