Associate Director , Regulatory Affairs

MSD; Pune District; Vor Ort; INR 4.000.000 - 6.400.000; Vollzeit

Zusammenfassung

MSD in India seeks an Associate Director of Regulatory Affairs to lead registration and compliance for imported and local biological/pharma products. You will develop global and local dossiers, coordinate with GOI authorities and internal stakeholders, ensuring timely regulatory submissions and license renewals.

The role requires extensive experience in regulatory strategy, cross-functional leadership, and strong English communication.

Qualifikationen

• Qualifications include BVSc & AH or related science, PGDMM desired, and 15 years in ethical veterinary market.
• Technical/market/product/disease knowledge, GOI authority rapport, and cross-functional collaboration are essential.

Aufgaben

• Registration of Imported Pharmaceuticals and Vaccines.
• Registration of local Biological & pharma Products.
• Development of dossiers for Export markets and local products.
• Renewal & maintenance of licenses (GMP/Manufacturing/Wholesale)
• Regulatory compliance for import products for clinical trials & CDTL testing.
• Provide documents for export registrations and approvals on time.
• Coordinate with Marketing for product artworks and regulatory requirements.
• Coordinate with international RA departments for India-specific requirements.
• Lead and develop RA team and establish processes.

Kenntnisse

Technical Knowledge

Market Knowledge

Product Knowledge

Disease knowledge

Rapport with GOI authorities

Relationship with drug authorities

Rapport with MoA & IVRI, DAHDF

Rapport with International teams

Good communication skills in English

Good networking skills

Ability to operate across cultural ZOZ

Common Technical Document

Cross-Functional Teamwork

Document Control Systems

Drug Registration

Electronic Submissions

Employee Training Programs

International Regulatory Compliance

Regulatory Strategy Development

Regulatory Submissions

Regulatory Affairs Management

Regulatory CMC

Regulatory Compliance

Regulatory Experience

Strategic Thinking

Team Leadership

Ausbildung

BVSc & AH or other related Science qualification

PGDMM Desired

15 years relevant experience in ethical veterinary market

Jobbeschreibung

Job Description Associate Director, Regulatory Affairs Registration of products for the Indian Market. To ensure compliance to all applicable laws and regulations in respect of Own and Contract Manufacturing of Company’s product. To ensure full Compliance to Internal Compliance policy. Development of Dossiers for export and local market. To liaise with concerned authorities for the above. To represent company in various Industry Forums. Strategic initiatives for new product developments through gap analysis. Strategic initiatives by identifying opportunities for improving the market share for company’s business.

ROLE RESPONSIBILITIES

Primary responsibilities critical to the performance of the role.

• Registration of Imported Pharmaceuticals and Vaccines.
• Registration of local Biological & pharma Products.
• Development of dossiers of local Biological and Pharmaceutical products for Export markets.
• Renewal & maintenance of all licenses - GMP/Manufacturing/Wholesale & others owned by company & CMO.
• Regulatory compliance to import products for clinical trials & CDTL testing.
• Providing requested documents for registration of products in Export markets & approving all artworks & other requisites on timely basis.
• Approval of artworks on imported & local products in accordance with country specific requirements in co-ordination with BU Heads and International Packaging.
• Initiation and co-ordination of Toxicity studies on Pharmaceutical Formulations and raw materials.
• Maintenance of Archives as a disciplined, safe & confidential record keeping
• Ensuring compliance with EHS, OHSAS and ISO standards in RA department.
• Plan and organize with International RA departments by providing current registration (document) requirements of India.
• Obtain required documents from local or international colleagues and submit applications for registration of products.
• To co-ordinate with Marketing for priorities and liaison Manager in Delhi for Registration of products.
• Develop systems and techniques in order to execute tasks which are required to be performed to accomplish RA objectives.
• Lead and develop subordinate to perform RA tasks and establish processes for routine jobs.
• Supervise the tasks performed by subordinates and provide guidance and assistance wherever required.
• Plan budget and organize equipment / tools to facilitate the efficient working of the RA department.
• To build teamwork within the department and facilitate co-ordination of RA team members with other departments.
• Review and approve artworks of products ensuring compliance with Regulatory requirements in co-ordination with Marketing and International Packaging services (Imported products).
• Develop International dossier for local biological products in co-ordination with GRA Boxmeer.
• Develop dossier of pharmaceutical products for Exports which meet customer country requirements.
• Co-ordinate with departments within the company and provide regulatory documents for registration of Products for Export markets.
• Coordinate with QC Pharma and outside laboratory to conduct Toxicity studies on Pharmaceuticals / raw materials and include the reports in respective product dossiers.
• Co-ordinate with VSD & technical team for regulatory compliance to conduct clinical trials.
• Maintaining archives of Dossiers of Imported and local products, technical literatures, Clinical trials / Safety & Efficacy Studies, Stability studies.
• Update documentation and ensure implementation of ISO and EHS standards and conduct audits as internal auditor.
• To be updated with the changes in regulatory requirements and initiate registration applications on time in accordance with current applicable procedures to ensure compliance.
• Expand technical knowledge on local and imported Pharmaceutical and Biological products to facilitate dossier development and registration.
• Developing good rapport with Regulatory authorities and ensuring proper co-ordination to obtain licenses.
• Keeping the team motivated irrespective of Regulatory hurdles faced during the Registration process.
• Acquire technical knowledge & providing required technical supportive data to the queries raised by the authorities especially for new product permissions & NOC.
• Development of new dossiers for all local products especially for old ones where we don’t have these & updating of old ones as per the approved changes.
• Co-ordinate with VSD & technical team for regulatory compliance to conduct clinical trials.
• Increase visibility & Maintain rapport with other organizations like CLFMA, OPPI, IDMA, KOL like Dairy, Poultry, Canine, Equine, Co-Operatives, NGO, Milk Unions, PDFA etc.
• Responsible for approval & renewal of physician’s Sample Policy along with country head as per the compliance policy & local laws of land like ma Drive pipeline of the company as per the approved five-year strategy in coordination with S&M teams as per the products screened year wise.

QUALIFICATIONS AND EXPERIENCE

Qualifications that are job related, consistent with business necessity and necessary for the performance of the essential functions of this role; includes education/licenses/certifications, relevant experience, technical and/or other job-related skills.

• BVSc & AH or other related Science qualification.
• PGDMM Desired.
• 15 year’s relevant experience in the ethical veterinary market.
• Technical Knowledge /Market Knowledge / Product Knowledge / Disease knowledge.
• Rapport with GOI authorities / Relationship with drug authorities Rapport with MoA & IVRI, DAHDF Rapport with International teams.
• Good communication skills in written and spoken English is preferred.
• Good networking skills.
• Ability to operate effectively across different cultural zones.

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products.

We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Additional location(s) Compensation Information: Required Skills: Common Technical Document, Cross-Functional Teamwork, Document Control Systems, Drug Registration, Electronic Submissions, Employee Training Programs, International Regulatory Compliance, Job Descriptions, Medical Device Regulations, New Product Development, New Product Qualification, People Leadership, Pharmaceutical Regulatory Affairs, Product Registrations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Experience, Regulatory Strategy Development, Regulatory Submissions, Strategic Thinking, Team Leadership