Job Description

Associate Director, Regulatory Affairs

This role is responsible for registration of products for the Indian Market, ensuring compliance to all applicable laws and regulations, development of Dossiers for export and local market, taking strategic initiatives for new product developments through gap analysis and by identifying opportunities for improving the market share for company\xe2\x80\x99s business.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Primary responsibilities include, but are not limited to:

• Registration of Imported Pharmaceuticals and Vaccines.
• Registration of local Biological and pharma products
• Development of dossiers of local Biological and Pharmaceutical products for Export markets.
• Renewal and maintenance of all licenses - GMP/Manufacturing/Whole sale and others owned by company and CMO.
• Regulatory compliance to import products for clinical trials and CDTL testing.
• Providing requested documents for registration of products in Export markets and approving all artworks and other requisites on timely basis.
• Approval of artworks on imported and 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 and 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.

The JD also includes the following Pharmacovigilance responsibilities:

• Overseeing, approving of product artworks and ensuring declaration of product safety data on labels
• Receiving the AE reports for submission to IHA\xe2\x80\x99s
• Overseeing the submissions of AE reports, maintaining and tracking the submission evidences.
• Variation submissions
• Ensuring Safety change declarations on packing elements and sending alerts to all the stake holders if any change in safety declarations is carried out in any VMP\xe2\x80\x99s
• 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 team-work 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 and technical team for regulatory compliance to conduct clinical trials.
• Maintaining archives of Dossiers of Imported and local products, Technical literatures, Clinical trials / Safety and 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 and providing required technical supportive data to the queries raised by the authorities especially for new product permissions and NOC.
• Development of new dossiers for all local products especially for old ones where we don\xe2\x80\x99t have these and updating of old ones as per the approved changes.
• Co-ordinate with VSD and technical team for regulatory compliance to conduct clinical trials.
• Increase visibility and 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 and renewal of physician\xe2\x80\x99s Sample Policy along with country head as per the compliance policy and 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 Skills

• 15 year\xe2\x80\x99s relevant experience in regulatory affairs with strong knowledge of regulatory
• Proven leadership qualities including the ability to identify talent, coach and develop.
• Excellent decision making and networking skills.
• Ability to work in uncertainty and complexity.
• Good communication skills in written and spoken English is preferred.

Current Employees apply

Current Contingent Workers apply

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

MSD