Global Regulatory Affairs Head
Michael Page
- Navi Mumbai, Maharashtra
- Permanent
- Full-time
*To liaise with appropriate authorities for the registration of products, within the stipulated time.
*To define filing strategies for advanced markets to identified products and ensure pre-approval, filing and post-approval activities.
*To manage the compliance of dossiers, checking accuracy/adequacy , end-to-end scheduling and approval of products; across ANDA and NDA.
*Responsible for managing global markets, majorly EU &US, being the face for meetings with Health Authorities, while working closely with the local counterparts in these markets.PRINCIPAL RESPONSIBILITIES
To work and ensure the highest professional standards in all aspects of Regulatory Affairs in accordance with the Company's key objectives, its philosophy and values. To ensure company's business interests are served and kept paramount at all times through fulfilment of the following responsibilities:
1. Regulatory Affairs:
*To prepare dossiers for registration of products.
*To deal with regulatory bodies, across the globe, majorly US & EU markets.
*To be involved in the dealings with the registration authorities at the top level and to get the products registered.
*To provide inputs to the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs.
*To assure conformity of dossiers to the local statutory requirements.
*To submit dossiers for products, like renewals of MAA or Variations, such as labelling changes, line extension, pharmaceutical changes (drug product composition, manufacturing site, etc.)
*To validate the pharmaceutical dossiers of the existing products (formulations).
*Maintaining a global network of regulatory professionals within HQ and beyond with affiliates and regions.
*To update the registration databases (sometimes different in the Affiliates and Corporate) and local regulations.
*To manage quality problems (complaints, batch recall, etc.)
2. Risk Management
*Within the scope of product risk management, represent the Company with the local Health Authorities and Health Care Providers where applicable.
3. Training and Awareness
*Ensure the Regulatory Affairs and Pharmacovigilance awareness and training of all employees of the companyBe a part of the leading specialty pharmaceutical CDMO for regulated markets|Opportunity to work with one of the fastest growing organization in the industryDESIRABLE CAPABILITIES
*Managerial maturity and strategic thinking capability to operate at Executive Committee level.
*Excellent knowledge of structure and operations of company and the Global Pharmaceutical market.
*Intimate familiarity with organization's product portfolio and disease areas underpinned by excellent scientific background.
*Outstanding analytical, organising, planning, communication, decision making and influencing skills.
*Demonstrate respect for and alignment with the Company's core values, mission and vision.The organization is into specialty pharmaceutical formulations focused on complex generics for regulated markets.Opportunity to work with a growing organization, invested in by a PE fund.
Opportunity to grow in a high visibility role.