Regulatory Affairs Director

2 weeks ago

Hyderabad, Telangana, India Demo S.A. Full time

DEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Global Services Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece and subsidiaries in Europe.

In the initial phase, the office will focus on Regulatory Affairs, supporting the development, registration, and lifecycle management of the company's pharmaceutical products. At a later stage, additional business services will be introduced, including Medical Affairs, IT & Digital Transformation, Procurement, and Quality.

To support its Regulatory Affairs operations, DEMO S.A. Pharmaceutical Industry is seeking a Regulatory Affairs Director. This individual will lead a team of RA specialists responsible for regulatory affairs activities related to the company's medicinal products in the EU and RoW countries.

The Regulatory Affairs Director will report to the Group Director of Corporate Development.

Responsibilities:

The RA Director will coordinate all necessary actions related to the activities described below in order to achieve an on-time and on-budget delivery of results based on the company's priorities.

Pre-approval operations:

The RA Director will support in-house regulatory dossier submissions as described below:

  • Participates in the product development process acting as the RA Subject Matter Expert
  • Contributes in shaping the regulatory strategy (legal basis, general requirements for clinical development /biowaiver) for new submissions
  • Determination of SmPC, PIL and labeling
  • Participates in the artwork approval process for any printed packaging materials
  • Preparation of the documents related to Modules 1-3 of the CTD dossier
  • Monitoring and supporting of the regulatory approval process until completion of the national phase in each country (responses in Deficiency Letters, handling of national phases)

Post-approval operations:

The RA Director will be responsible for coordinating all product lifecycle activities for the company's registered products in EU and RoW countries. This may include:

  • Preparation of variation dossiers
  • Submission and monitoring until final (national) approval of the variations (responses in Deficiency Letters, handling of national phases)
  • Preparation and monitoring until final approval of any renewals of Marketing Authorizations.
  • Monitoring of any other post-approval regulatory activities (e.g. sunset clause).

Managerial responsibilities:

  • Supervision of the team
  • Alignment with the company's strategy
  • Training of the team
  • Monitoring of the team's performance based on the well-established KPIs
  • Reporting of deliverables to the top management

Requirements

  • BSc in Chemistry, Biology, or a related field; an MSc will be considered an asset.
  • 8+ years of experience in Regulatory Affairs in the generic pharmaceutical industry.
  • Fluent in English (spoken and written) with strong MS Office skills.
  • Excellent organizational skills, ability to multitask, and meet deadlines.
  • Strong leadership and team management abilities.
  • Effective communication and relationship management skills.
  • In-depth knowledge of global regulatory guidelines.
  • Ability to work under pressure with resilience.

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

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