Senior Manager – Regulatory Affairs

Full-time position

Min Experience - 12 years

Whitefield, Bangalore

Qualification
B.Pharm / M.Pharm / M.Sc.
POSITION OVERVIEW:
  • Preparing & Filing of product applications (Solid Dosage Forms & External preparations) in USA, EU, China, Australia etc and other regulated market as applicable
  • Planning & Execution of Product Dossiers as per scheduled planner & submissions
  • Review of dossiers to ensure major queries are not expected from any Regulatory Agencies
  • To prepare and provide strong Regulatory Strategy specific to the therapeutic category of the product for the successful Pre-IND meeting
  • Review of Pre-Clinical Studies design as per the Global submission requirements
  • Review and response of Product related Citizen Petitions
  • Strong knowledge on GDUFA /PDUFA related activities
  • Review of Pre-Clinical study Reports and compilation of STF’s
  • Selection of suitable Reference Product and design the BE / BA study as per the country requirements
  • Preparation and compilation IND draft labeling as per the New Drug Application requirements
  • Strong knowledge on handling of New Drug Applications
  • Provide technical assistance to the team details of Pre-Clinical studies design and provide scientific evidence
  • Review of different phases of Clinical Trial Applications
  • Handling of Amendments to FDA (Gratuitous, complete response, Telephonic labeling, Easily correctable Deficiencies and Bio-Amendments)
  • Drafting of Patent Applications for both API & Formulations
  • Handling of Supplements (PAS,CBE-0 and CBE-30) and Annual reports to USFDA
  • To prepare and provide strong regulatory strategy specific to the therapeutic category of the product for the successful Pre-IND meeting outcome with the help of consultant
  • To provide logistic for the arrangement of Pre-IND meeting with USFDA
  • Co-ordination of cross functional teams (CFT’s) / contract research organizations (CRO’s) to get technical documents required for the preparation of Pre-IND meeting briefing package
  • Review of CMC, Non-Clinical and Clinical documents for scientific and technical content and compliance with regulatory requirements
  • Review of investigator brochure in accordance to the country regulatory requirements
  • GAP analysis report preparation with remediation
  • Compilation and preparation of DMF Dossiers in eCTD format (open part & restricted parts)
  • Handling of Lorenz software and publishing the eCTD independently
  • Knowledge of serialization and handling of the concern activities pertaining to RA like creation of product profile data and submission of batch data to EU HUB
  • Pre-IND meeting briefing package compilation, preparation and finalization and submission with USFDA/EMA/AUS with the help of consultants
  • To participate in all the R&D meetings and provide regulatory inputs
  • To provide regulatory and CMC support for all phases of product development for different types of pharmaceutical products
  • Identification of suitable CRO’s for conduction clinical trials, patient BE/PK studies & Audits of CRO facilities and negotiation of trial timelines and allocation of studies
  • Identification, review and preparation of SOP’s related to Regulatory and Clinical Research with the help of Medical affairs as applicable
  • Review of trial related documents: site initiation, monitoring, closure reports/reviewing and overseeing of CRO-SIV’s, SMV reports (onsite & offsite)
  • Review of different phase study protocols, ICF’s, CRF’s, TMF’s, SMF’s , subject diaries, Regulatory documents and clinical trial reports as per the ICH-GCP, protocol and applicable guidelines
  • To ensure Regulatory Compliance in the organization
  • To advise and guide research and development on Regulatory requirements for new product development and registration of the products with USFDA / EU / EMA
  • Primary point of contact between cross functional teams and consultants
  • Review, finalization and approval of license related documents to start API and formulation R&D activities and also ensuring timely submission and early approval from local regulatory authorities
  • To bring the best talent pool to the organization by identifying, evaluating and engaging for resources hiring and talent management etc
  • Correspondence with applicable regulatory/PhV consultant
Desired Candidate Profile:
  • A Pharmacy/ Science Graduate/Postgraduate from well-established Regulatory background with 10 to 12 years sound experience in reputed Pharma Organizations
  • Ability to work both independently and within a team structure
  • Proven ability to lead, influence and motivate colleagues and external partners
  • Good knowledge of guidelines from EUDRA, FDA, TGA, MCC and ANVISA
  • Strong planning, presentation, and interpersonal skills
  • Strong work ethic, self-motivation, dedication, results orientation
  • Significant working knowledge of the pharmaceutical product development process (eg. Regulatory requirements, GMP, Clinical strategies, drug delivery etc.)
  • Understanding of the role of drug delivery in the pharmaceutical marketplace in both scientific and business context (eg. Market exclusivity requirements, role of IP in life cycle management) is a plus
  • Working knowledge on the various Biotechnological techniques, Gene therapy and Gene silencing techniques is a plus
  • Excellent in written and spoken English
  • Multitasker, strong in systems, process
  • Can do attitude is a must
  • Evaluation of strategic option, costs, time and completion strategy
  • Strong internal co-ordination skills

BIOPLUS does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, marital status, or based on an individual’s status in any group or class protected by applicable law.

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