General Manager - Regulatory Affairs - Pharma

JOB DESCRIPTION:

- Preparing & Filing of product applications (Solid Dosage Forms & External preparations) in USA, EU, China, Australia etc-

- 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)

- 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

- 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.

Desired Candidate Profile:

- A Pharmacy/ Science Graduate/Post Graduate from well-established Regulatory background with 18 to 20 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

- Multi tasker, strong in systems, process

- Can do attitude is a must

- Evaluation of strategic option, costs, time and completion strategy

- Strong internal co-ordination skills